press release
Nov. 28, 2011, 11:21 a.m. EST
SASKATOON, Saskatchewan, Nov 28, 2011 (BUSINESS WIRE) -- AdeTherapeutics, Inc. received Health Canada approval in November to conduct a double-blind randomized placebo controlled study in 30 patients to test its therapeutic to reduce adhesion (scar tissue) formation following laparoscopic procedure to remove an ectopic pregnancy.
Designed by surgeons, the trial is powered to potentially establish standard of care. The novel mechanism, which modulates normal healing process, is also being studied in other surgical areas of high unmet medical need.
The trial will be conducted at teaching hospitals in Canada with first patient enrolment expected in December 2011.
Click here to read the rest: http://www.marketwatch.com/story/adetherapeutics-inc-health-canada-approves-clinical-trial-for-adhesion-prevention-2011-11-28
Wednesday, November 30, 2011
Saturday, November 26, 2011
Solos Endoscopy Poised for Tremendous Growth in Multi-Billion Dollar Endoscopic Market
By Solos Endoscopy, Inc.
Solos Endoscopy, Inc.
Last modified: 2011-11-17T15:54:24Z
Published: Thursday, Nov. 17, 2011 - 7:54 am
BOSTON, Nov. 17, 2011 -- /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company is positioned for tremendous growth in the multi-billion dollar endoscopic market. Solos Endoscopy currently has its endoscopic instruments in over 60 Hospitals, Clinics, Healthcare Centers, Medical Centers and Surgery Centers across the United States with plans to market its endoscopic instrument internationally upon receiving the CE Mark.
Meltwater News Inc., a global specialist in online media monitoring, has delivered a report highlighting significant growth in the endoscopy market over the next five years. According to MarketResearch.com in its July 2011 report, the overall medical device market is very large; endoscopy is a significant component of that market. The endoscopy market is positioned for significant growth in the next 5 years. The endoscopy market worldwide was $23.3 billion in 2010 and is projected to reach nearly $24.8 billion in 2011. This is further anticipated to increase to $33.7 billion by 2016 at a compound annual growth rate (CAGR) of 6.4%.
Laparoscopy accounts for more than 26% of the total market and is expected to reach $6.8 billion by end of 2011 and to increase up to $10.6 billion by 2016 at a compound annual growth rate (CAGR) of 9.2%.
Endoscopy of the GI track for tumors, adhesions, diverticulitis, etc. is projected to experience an increase from $3.7 billion in 2011 to more than $4.9 billion in 2016, a CAGR of 5.7%.
This is due, in part, to new applications for the technology, as well as new innovations in the technology itself. The other major factor that will contribute to this growth is the recognition of this technology in emerging markets like Japan and Vietnam. Continued worldwide growth is expected in other geographic areas due to a growing middle class in countries such as India, China, Brazil, and Russia.
For more information on Meltwater News Inc., please visit; www.meltwater.com
About Solos Endoscopy, Inc.:
Solos Endoscopy, Inc. is a HealthCare instrument company whose mission is to develop and market high quality and innovative instruments for the screening, diagnosis, treatment and management of medical conditions. Additional information on its FDA approved products is available on the Company's website at: www.solosendoscopy.com.
Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, ability to obtain financing and regulatory and shareholder approval for anticipated actions.
Contact: Amanda Segersten, rsegersten@solosendoscopy.com
SOURCE Solos Endoscopy, Inc.
Read more: http://www.sacbee.com/2011/11/17/4061951/solos-endoscopy-poised-for-tremendous.html#ixzz1eoZSvUI f
Solos Endoscopy, Inc.
Last modified: 2011-11-17T15:54:24Z
Published: Thursday, Nov. 17, 2011 - 7:54 am
BOSTON, Nov. 17, 2011 -- /PRNewswire/ -- Solos Endoscopy, Inc. (OTCPK: SNDY) is pleased to announce that the Company is positioned for tremendous growth in the multi-billion dollar endoscopic market. Solos Endoscopy currently has its endoscopic instruments in over 60 Hospitals, Clinics, Healthcare Centers, Medical Centers and Surgery Centers across the United States with plans to market its endoscopic instrument internationally upon receiving the CE Mark.
Meltwater News Inc., a global specialist in online media monitoring, has delivered a report highlighting significant growth in the endoscopy market over the next five years. According to MarketResearch.com in its July 2011 report, the overall medical device market is very large; endoscopy is a significant component of that market. The endoscopy market is positioned for significant growth in the next 5 years. The endoscopy market worldwide was $23.3 billion in 2010 and is projected to reach nearly $24.8 billion in 2011. This is further anticipated to increase to $33.7 billion by 2016 at a compound annual growth rate (CAGR) of 6.4%.
Laparoscopy accounts for more than 26% of the total market and is expected to reach $6.8 billion by end of 2011 and to increase up to $10.6 billion by 2016 at a compound annual growth rate (CAGR) of 9.2%.
Endoscopy of the GI track for tumors, adhesions, diverticulitis, etc. is projected to experience an increase from $3.7 billion in 2011 to more than $4.9 billion in 2016, a CAGR of 5.7%.
This is due, in part, to new applications for the technology, as well as new innovations in the technology itself. The other major factor that will contribute to this growth is the recognition of this technology in emerging markets like Japan and Vietnam. Continued worldwide growth is expected in other geographic areas due to a growing middle class in countries such as India, China, Brazil, and Russia.
For more information on Meltwater News Inc., please visit; www.meltwater.com
About Solos Endoscopy, Inc.:
Solos Endoscopy, Inc. is a HealthCare instrument company whose mission is to develop and market high quality and innovative instruments for the screening, diagnosis, treatment and management of medical conditions. Additional information on its FDA approved products is available on the Company's website at: www.solosendoscopy.com.
Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, ability to obtain financing and regulatory and shareholder approval for anticipated actions.
Contact: Amanda Segersten, rsegersten@solosendoscopy.com
SOURCE Solos Endoscopy, Inc.
Read more: http://www.sacbee.com/2011/11/17/4061951/solos-endoscopy-poised-for-tremendous.html#ixzz1eoZSvUI f
Monday, November 21, 2011
Clinical trial will aim to reduce surgical scarring
By Janet French, The StarPhoenix November 19, 2011
A Saskatoon biotechnology company is preparing to launch a clinical trial of a new drug it says could help reduce surgical complications.
Health Canada has given AdeTherapeutics permission to proceed with clinical trials for Evitar, a compound the company says can help reduce scarring from surgery.
Obstetricians and Gynecologists in Saskatoon will be the first to try out Evitar on humans, starting with women who have ectopic pregnancies. An ectopic pregnancy is a non-viable embryo that implants in tissue outside a woman’s womb. A rupture can threaten a woman’s life, and the embryo must be surgically removed.
Lead by principal investigator Dr. Donna Chizen, participating surgeons at City and Royal University hospitals will ask women diagnosed with ectopic pregnancies if they’re willing to join the trial, says Sanj Singh, president and CEO if AdeTherapeutics.
“The patients will be more than willing (to join) because the ectopics lead to such bad complications for future pregnancies that they’re very keen on any type of treatment that will help with future fertility,” Singh said.
According to the U.S. National Institutes of Health, only a third of women who have an ectopic pregnancy are able to later have a baby.
Many surgeries leave scar tissue in their wake as the body heals imperfectly, and that scarring often causes pain and complications, Singh said.
“Ninety-three per cent of surgeries result in scar tissue,” Singh said. “One in three readmissions back in hospital are due to complications like scar tissue.”
Read more: http://www.thestarphoenix.com/health/Clinical+trial+will+reduce+surgical+scarring/5734819/story.html#ixzz1eKpvZGGL
A Saskatoon biotechnology company is preparing to launch a clinical trial of a new drug it says could help reduce surgical complications.
Health Canada has given AdeTherapeutics permission to proceed with clinical trials for Evitar, a compound the company says can help reduce scarring from surgery.
Obstetricians and Gynecologists in Saskatoon will be the first to try out Evitar on humans, starting with women who have ectopic pregnancies. An ectopic pregnancy is a non-viable embryo that implants in tissue outside a woman’s womb. A rupture can threaten a woman’s life, and the embryo must be surgically removed.
Lead by principal investigator Dr. Donna Chizen, participating surgeons at City and Royal University hospitals will ask women diagnosed with ectopic pregnancies if they’re willing to join the trial, says Sanj Singh, president and CEO if AdeTherapeutics.
“The patients will be more than willing (to join) because the ectopics lead to such bad complications for future pregnancies that they’re very keen on any type of treatment that will help with future fertility,” Singh said.
According to the U.S. National Institutes of Health, only a third of women who have an ectopic pregnancy are able to later have a baby.
Many surgeries leave scar tissue in their wake as the body heals imperfectly, and that scarring often causes pain and complications, Singh said.
“Ninety-three per cent of surgeries result in scar tissue,” Singh said. “One in three readmissions back in hospital are due to complications like scar tissue.”
Read more: http://www.thestarphoenix.com/health/Clinical+trial+will+reduce+surgical+scarring/5734819/story.html#ixzz1eKpvZGGL
Sunday, November 20, 2011
Awareness and perception of intra-abdominal adhesions and related consequences: survey of gynaecologists in German hospitals.
Eur J Obstet Gynecol Reprod Biol. 2010 Jun;150(2):180-9. Epub 2010 Mar 16.
Awareness and perception of intra-abdominal adhesions and related consequences: survey of gynaecologists in German hospitals.
Hackethal A, Sick C, Brueggmann D, Tchartchian G, Wallwiener M, Muenstedt K, Tinneberg HR.
SourceDepartment of Obstetrics and Gynaecology, Justus-Liebig-University of Giessen, Giessen, Germany. andreas.hackethal@gyn.med.uni-giessen.de
Abstract
OBJECTIVE: Intra-abdominal adhesion formation after abdominal surgery is the most common postsurgical complication, and the consequences are a considerable burden for patients, surgeons and health systems. Since a wide variety of factors influence adhesion formation, it is difficult to define clear guidelines on how to reduce adhesion formation in daily practice. Given this dilemma, this study assessed the awareness and perception of adhesion formation among gynaecologists in Germany in order to define a baseline for further research and education.
STUDY DESIGN: The Clinical Adhesion Research and Evaluation (CARE) group of the University of Giessen designed a questionnaire that was sent to the heads of all gynaecological departments in Germany. The director or one of the surgical consultants was asked to complete the questionnaire and return it for evaluation.
RESULTS: The completed questionnaire was returned by 279 of 833 gynaecological departments. Interviewed surgeons expected adhesions to form in 15% of cases after laparoscopy and 40% after laparotomy. Before surgery, 83.1% of the respondents told their patients about the risk of prior adhesion formation. More than 60% believed that postsurgical adhesion accounts for major morbidity. Infections within the abdomen, previous surgery and extensive tissue trauma were thought to have the most influence on adhesion formation. Risk of adhesion formation was thought to be highest in endometriosis and adhesiolysis surgery. The respondents agreed on performing adhesiolysis in symptomatic but not in all patients. Only 38.4% used adhesion reduction agents regularly. A total of 65.1% of a repertoire of adhesion prevention agents were familiar to the interviewed surgeons. Only 22.0% of them used anti-adhesion products in clinical practice. In general, the respondents were uncertain whether these products play an important role in adhesion reduction, represented by a range of 1.97+/-0.98% on a scale from 0 to 4.
CONCLUSIONS: Even though postoperative adhesions are recognized as a major cause for morbidity, and it is widely agreed that infections, extensive tissue trauma and surgery lead to adhesion formation, there is uncertainty about the treatment and prophylactic strategies for dealing with adhesions. This dilemma reflects the awareness and perception of gynaecologists in Germany and is an initial point for further research.
Copyright 2010 Elsevier Ireland Ltd. All rights reserved.
PMID:20236750[PubMed - indexed for MEDLINE]
Awareness and perception of intra-abdominal adhesions and related consequences: survey of gynaecologists in German hospitals.
Hackethal A, Sick C, Brueggmann D, Tchartchian G, Wallwiener M, Muenstedt K, Tinneberg HR.
SourceDepartment of Obstetrics and Gynaecology, Justus-Liebig-University of Giessen, Giessen, Germany. andreas.hackethal@gyn.med.uni-giessen.de
Abstract
OBJECTIVE: Intra-abdominal adhesion formation after abdominal surgery is the most common postsurgical complication, and the consequences are a considerable burden for patients, surgeons and health systems. Since a wide variety of factors influence adhesion formation, it is difficult to define clear guidelines on how to reduce adhesion formation in daily practice. Given this dilemma, this study assessed the awareness and perception of adhesion formation among gynaecologists in Germany in order to define a baseline for further research and education.
STUDY DESIGN: The Clinical Adhesion Research and Evaluation (CARE) group of the University of Giessen designed a questionnaire that was sent to the heads of all gynaecological departments in Germany. The director or one of the surgical consultants was asked to complete the questionnaire and return it for evaluation.
RESULTS: The completed questionnaire was returned by 279 of 833 gynaecological departments. Interviewed surgeons expected adhesions to form in 15% of cases after laparoscopy and 40% after laparotomy. Before surgery, 83.1% of the respondents told their patients about the risk of prior adhesion formation. More than 60% believed that postsurgical adhesion accounts for major morbidity. Infections within the abdomen, previous surgery and extensive tissue trauma were thought to have the most influence on adhesion formation. Risk of adhesion formation was thought to be highest in endometriosis and adhesiolysis surgery. The respondents agreed on performing adhesiolysis in symptomatic but not in all patients. Only 38.4% used adhesion reduction agents regularly. A total of 65.1% of a repertoire of adhesion prevention agents were familiar to the interviewed surgeons. Only 22.0% of them used anti-adhesion products in clinical practice. In general, the respondents were uncertain whether these products play an important role in adhesion reduction, represented by a range of 1.97+/-0.98% on a scale from 0 to 4.
CONCLUSIONS: Even though postoperative adhesions are recognized as a major cause for morbidity, and it is widely agreed that infections, extensive tissue trauma and surgery lead to adhesion formation, there is uncertainty about the treatment and prophylactic strategies for dealing with adhesions. This dilemma reflects the awareness and perception of gynaecologists in Germany and is an initial point for further research.
Copyright 2010 Elsevier Ireland Ltd. All rights reserved.
PMID:20236750[PubMed - indexed for MEDLINE]
Laparoscopic Lysis of Abdominal Adhesions
A really simple 3D video of what will happen to you during an adhesiolysis ~ surgery to tkae down adhesions.
Saturday, November 19, 2011
December 15, 1886 Cause of Death: Adhesions of Bowels
Deceased Name: Parker Boggs
Gender: Male
Date of Death: December 15, 1886
Cause of Death: Adhesions of Bowels
Age: 18
Father's Name: E. Boggs
Mother's Name: E. J.
Mother's Maiden Name: Naper
http://www.ingenweb.org/inrandolph/HealthDept/Death/RichardsonCollection.htm
Gender: Male
Date of Death: December 15, 1886
Cause of Death: Adhesions of Bowels
Age: 18
Father's Name: E. Boggs
Mother's Name: E. J.
Mother's Maiden Name: Naper
http://www.ingenweb.org/inrandolph/HealthDept/Death/RichardsonCollection.htm
Thursday, November 17, 2011
Effect of bovine amniotic fluid on intra-abdominal adhesion in diabetic male rats.
J Diabetes Complications. 2011 Jan-Feb;25(1):39-43. Epub 2009 Oct 13.
Effect of bovine amniotic fluid on intra-abdominal adhesion in diabetic male rats.
Abbasian B, Kazemini H, Esmaeili A, Adibi S.
SourceFaculty of Veterinary Medicine, Shahrekord Azad University, Shahrekord, Iran.
Abstract
BACKGROUND: Postsurgical adhesion formation is a significant clinical problem within every surgical specialty. In type I diabetic patients, the problem is more severe and wound healing is slow. A wide variety of treatments have been proposed to deal with the problems that adhesion causes. One of the modalities that have not been studied extensively yet is the use of amniotic fluid. The purpose of the present study was to evaluate the clinical value of bovine amniotic fluid (BAF) efficacy in the treatment of postsurgical adhesion formation in diabetic male rats.
MATERIALS AND METHODS: Fifty male Wistar rats in five groups were used for our study, with animal identification being facilitated by a microchip implant system. Diabetes was induced in all groups except for the control group by intraperitoneal alloxan injection (120 mg/kg). Based upon blood glucose concentration, rats received either one third of the required insulin (two groups) or all the required insulin (remaining groups). After 2 weeks, a laparotomy was performed on each rat and adhesions were scaled. Bovine amniotic fluid was then applied to two groups, and, as a control, sterilized water was applied to the other groups. After 2 weeks, a laparotomy was again performed on each rat and adhesion was rescored.
RESULTS AND CONCLUSION: Significant reductions (P<.05) in adhesions were seen with BAF only in those diabetic rats that had received the required insulin. The results of our study suggest that BAF could be effective in the treatment of adhesion formation during diabetes.
Copyright © 2011 Elsevier Inc. All rights reserved.
PMID:19828333[PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/19828333
Effect of bovine amniotic fluid on intra-abdominal adhesion in diabetic male rats.
Abbasian B, Kazemini H, Esmaeili A, Adibi S.
SourceFaculty of Veterinary Medicine, Shahrekord Azad University, Shahrekord, Iran.
Abstract
BACKGROUND: Postsurgical adhesion formation is a significant clinical problem within every surgical specialty. In type I diabetic patients, the problem is more severe and wound healing is slow. A wide variety of treatments have been proposed to deal with the problems that adhesion causes. One of the modalities that have not been studied extensively yet is the use of amniotic fluid. The purpose of the present study was to evaluate the clinical value of bovine amniotic fluid (BAF) efficacy in the treatment of postsurgical adhesion formation in diabetic male rats.
MATERIALS AND METHODS: Fifty male Wistar rats in five groups were used for our study, with animal identification being facilitated by a microchip implant system. Diabetes was induced in all groups except for the control group by intraperitoneal alloxan injection (120 mg/kg). Based upon blood glucose concentration, rats received either one third of the required insulin (two groups) or all the required insulin (remaining groups). After 2 weeks, a laparotomy was performed on each rat and adhesions were scaled. Bovine amniotic fluid was then applied to two groups, and, as a control, sterilized water was applied to the other groups. After 2 weeks, a laparotomy was again performed on each rat and adhesion was rescored.
RESULTS AND CONCLUSION: Significant reductions (P<.05) in adhesions were seen with BAF only in those diabetic rats that had received the required insulin. The results of our study suggest that BAF could be effective in the treatment of adhesion formation during diabetes.
Copyright © 2011 Elsevier Inc. All rights reserved.
PMID:19828333[PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/19828333
Severe inflammatory reaction induced by peritoneal trauma is the key driving mechanism of postoperative adhesion formation
CO2 insufflation however, led to moderate inflammation and less adhesion formation.
http://7thspace.com/headlines/399719/severe_inflammatory_reaction_induced
_by_peritoneal_trauma_is_the_key_driving_mechanism_of_postoperative_adhesion_formation_.html
Many factors have been put forward as a driving mechanism of surgery-triggered adhesion formation (AF). In this study, we underline the key role of specific surgical trauma related with open surgery (OS) and laparoscopic (LS) conditions in postoperative AF and we aimed to study peritoneal tissue inflammatory reaction (TIR), remodelling specific complications of open surgery (OS) versus LS and subsequently evaluating AF induced by these conditions.
Methods: A prospective randomized study was done in 80 anaesthetised female Wistar rats divided equally into 2 groups.
Specific traumatic OS conditions were induced by midline incision line (MLI) extension and tissue drying and specific LS conditions were remodelled by CO2 insufflation. TIR was evaluated at the 24th, 72nd, 120th and 168th hour by scoring scale.
Statistical analysis was performed by the non parametric t test and two-way ANOVA using Bonferroni post-tests.
Results: More pronounced residual TIR was registered after OS than after LS. There were no significant TIR interactions though highly significant differences were observed between the OS and LS groups (p<0.0001) with regard to surgical and time factors. The TIR change differences between the OS and LS groups were pronounced with postoperative time p<0.05 at the 24th and 72nd; p<0.01 - 120th and p<0.001 - 168th hrs. Adhesion free wounds were observed in 20.0 and 31.0% of cases after creation of OS and LS conditions respectively; with no significant differences between these values (p>0.05).
However larger adhesion size (41.6733.63) was observed after OS in comparison with LS (20.3116.38). The upper-lower 95% confidential limits ranged from 60.29 to 23.04 and from 29.04 to 11.59 respectively after OS and LS groups with significant differences (p=0.03).
Analogous changes were observed in adhesion severity values. Subsequently, severe TIR parameters were followed by larger sizes of severe postoperative adhesions in the OS group than those observed in the LS group.
Conclusions: MIL extension and tissue drying seem to be the key factors in the pathogenesis of adhesion formation, triggering severe inflammatory reactions of the peritoneal tissue surrounding the MIL resulting in local and systemic consequences.
CO2 insufflation however, led to moderate inflammation and less adhesion formation.
Author: Sergei PismenskyZhomart KalzhanovMarina EliseevaIoannis KosmasOspan Mynbaev
Credits/Source: BMC Surgery 2011, 11:30
http://7thspace.com/headlines/399719/severe_inflammatory_reaction_induced
_by_peritoneal_trauma_is_the_key_driving_mechanism_of_postoperative_adhesion_formation_.html
Many factors have been put forward as a driving mechanism of surgery-triggered adhesion formation (AF). In this study, we underline the key role of specific surgical trauma related with open surgery (OS) and laparoscopic (LS) conditions in postoperative AF and we aimed to study peritoneal tissue inflammatory reaction (TIR), remodelling specific complications of open surgery (OS) versus LS and subsequently evaluating AF induced by these conditions.
Methods: A prospective randomized study was done in 80 anaesthetised female Wistar rats divided equally into 2 groups.
Specific traumatic OS conditions were induced by midline incision line (MLI) extension and tissue drying and specific LS conditions were remodelled by CO2 insufflation. TIR was evaluated at the 24th, 72nd, 120th and 168th hour by scoring scale.
Statistical analysis was performed by the non parametric t test and two-way ANOVA using Bonferroni post-tests.
Results: More pronounced residual TIR was registered after OS than after LS. There were no significant TIR interactions though highly significant differences were observed between the OS and LS groups (p<0.0001) with regard to surgical and time factors. The TIR change differences between the OS and LS groups were pronounced with postoperative time p<0.05 at the 24th and 72nd; p<0.01 - 120th and p<0.001 - 168th hrs. Adhesion free wounds were observed in 20.0 and 31.0% of cases after creation of OS and LS conditions respectively; with no significant differences between these values (p>0.05).
However larger adhesion size (41.6733.63) was observed after OS in comparison with LS (20.3116.38). The upper-lower 95% confidential limits ranged from 60.29 to 23.04 and from 29.04 to 11.59 respectively after OS and LS groups with significant differences (p=0.03).
Analogous changes were observed in adhesion severity values. Subsequently, severe TIR parameters were followed by larger sizes of severe postoperative adhesions in the OS group than those observed in the LS group.
Conclusions: MIL extension and tissue drying seem to be the key factors in the pathogenesis of adhesion formation, triggering severe inflammatory reactions of the peritoneal tissue surrounding the MIL resulting in local and systemic consequences.
CO2 insufflation however, led to moderate inflammation and less adhesion formation.
Author: Sergei PismenskyZhomart KalzhanovMarina EliseevaIoannis KosmasOspan Mynbaev
Credits/Source: BMC Surgery 2011, 11:30
Agreement With Innocoll for Surgical Adhesion Barrier CollaGUARD
TORONTO, ONTARIO, Nov 14, 2011 (MARKETWIRE via COMTEX) -- Envoy Capital Group Inc. /quotes/zigman/38441 CA:ECG +8.46% /quotes/zigman/38429/quotes/nls/ecgi ECGI +0.94% ("Envoy") announces that Merus Labs International Inc. (cnsx:MR) ("Merus") has entered into a License and Distribution Agreement with Innocoll in Canada for CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery. Envoy and Merus Labs have agreed to amalgamate subject to shareholder and regulatory approval as earlier announced. Meetings of shareholder of Envoy and Merus have been scheduled for December 9, 2011.
"Adhesions occur after most surgical procedures, and are of major clinical, social and economic concern. The addition of CollaGUARD to our portfolio means that thousands of patients at risk of adhesion will have a clinically proven superior solution. We look forward to obtaining Health Canada approval and the launch of CollaGUARD in 2012." said Ali Moghaddam, Vice President at Merus Labs.
Dr. Michael Myers, President and CEO of Innocoll stated, "We are pleased to announce the expansion of our partnership with Merus to include CollaGUARD and we look forward to the successful launch of the product in Canada."
About CollaGUARD(R)
CollaGUARD is a transparent bioresorbable film of 100% type I collagen developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P less than 0.001) and significantly reduced the extent and severity of adhesions (P less than 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx(R), CollaFilm, DermaSil(TM), CollaPress(TM) and Liquicoll(R). Approved products based on the Company's technologies include: Collatamp(R) G, Septocoll(R), CollaGUARD, Collieva(R), CollaCare(R), Collexa(R), Zorpreva(TM), and LidoColl(R).
Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com .
Read More : http://www.marketwatch.com/story/envoy-capital-announces-merus-labs-licensing-agreement-with-innocoll-for-surgical-adhesion-barrier-collaguard-2011-11-14-943190?reflink=MW_news_stmp
"Adhesions occur after most surgical procedures, and are of major clinical, social and economic concern. The addition of CollaGUARD to our portfolio means that thousands of patients at risk of adhesion will have a clinically proven superior solution. We look forward to obtaining Health Canada approval and the launch of CollaGUARD in 2012." said Ali Moghaddam, Vice President at Merus Labs.
Dr. Michael Myers, President and CEO of Innocoll stated, "We are pleased to announce the expansion of our partnership with Merus to include CollaGUARD and we look forward to the successful launch of the product in Canada."
About CollaGUARD(R)
CollaGUARD is a transparent bioresorbable film of 100% type I collagen developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P less than 0.001) and significantly reduced the extent and severity of adhesions (P less than 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx(R), CollaFilm, DermaSil(TM), CollaPress(TM) and Liquicoll(R). Approved products based on the Company's technologies include: Collatamp(R) G, Septocoll(R), CollaGUARD, Collieva(R), CollaCare(R), Collexa(R), Zorpreva(TM), and LidoColl(R).
Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com .
Read More : http://www.marketwatch.com/story/envoy-capital-announces-merus-labs-licensing-agreement-with-innocoll-for-surgical-adhesion-barrier-collaguard-2011-11-14-943190?reflink=MW_news_stmp
Saturday, November 12, 2011
Bowel Obstruction: Gas Pattern and Presentations
http://www.youtube.com/watch?v=H0Rg9FvynqE&feature=related
Thursday, November 10, 2011
Immune Response to Biologic Scaffold Materials
Immune Response to Biologic Scaffold MaterialsCorresponding author: Stephen F. Badylak, McGowan Institute for Regenerative Medicine, University of Pittsburgh, 100 Technology Drive, Suite 200, Pittsburgh, PA 15219, P: (412) 235-5144, F: (412) 235-5110, Email: badylaks@upmc.edu
Stephen F. Badylak and Thomas W. Gilbert
McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, PA
Summary
In summary, allogeneic and xenogeneic biologic scaffolds composed of extracellular matrix are commonly used in numerous tissue engineering and regenerative medicine applications, and in many reconstructive surgical procedures. The effect of such scaffolds upon the host immune response has been largely unexplored. In addition, the association between the host immune response and tissue remodeling events is a factor that logically plays an important, if not determinative, role in the successful clinical application of these devices. There are many variables in the manufacturing of matrix derived scaffolds and all of these variables can affect the host immune response. An improved understanding of the immune response to biologic scaffold materials can only lead to greater safety and efficiency of devices and applications that utilize such materials.
Read Full abstract here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2605275/
Stephen F. Badylak and Thomas W. Gilbert
McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, PA
Summary
In summary, allogeneic and xenogeneic biologic scaffolds composed of extracellular matrix are commonly used in numerous tissue engineering and regenerative medicine applications, and in many reconstructive surgical procedures. The effect of such scaffolds upon the host immune response has been largely unexplored. In addition, the association between the host immune response and tissue remodeling events is a factor that logically plays an important, if not determinative, role in the successful clinical application of these devices. There are many variables in the manufacturing of matrix derived scaffolds and all of these variables can affect the host immune response. An improved understanding of the immune response to biologic scaffold materials can only lead to greater safety and efficiency of devices and applications that utilize such materials.
Read Full abstract here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2605275/
Wednesday, November 09, 2011
Innocoll Enters Partnership With Pioneer Pharma in China for the Distribution of CollaGUARD
ASHBURN, Va. ,Oct. 19, 2011 /PRNewswire/ -- Innocoll, Inc. announced it has entered into a License and Distribution Agreement with Pioneer Pharma in China for CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery.
Dr. Michael Myers, President and CEO stated "This is an exciting development for Innocoll. China is becoming an increasingly important and dynamic market for medical products and we are very pleased to have established this partnership with such an innovative company as Pioneer. I look forward to exploring additional partnership opportunities between our two companies."
Mr. XinZhou Li, President and CEO from Pioneer Pharma stated "We are very excited to have finally reached the partnership agreement with Innocoll. Let us mark this day with remembrance as CollaGUARD will become a very important product in our current distribution channel. We believe that CollaGUARD® has significant market potential and Pioneer will try to make it happen. "
About CollaGUARD®
CollaGUARD is a transparent bioresorbable film of 100% type I collagen developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P < 0.001) and significantly reduced the extent and severity of adhesions (P < 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
About Postoperative Adhesions
Postoperative adhesions are abnormal fibrous connections that can form between any apposing internal organ and serous membrane as a natural consequence of abdominopelvic surgery. Adhesions occur in almost 95% of laparotomies and may lead to serious complications such as intestinal obstruction, secondary female infertility, and chronic abdominal or pelvic pain. More than 30% of patients who undergo open gynecologic or general surgery are readmitted within 10 years for disorders that are considered directly or potentially related to adhesions, with an average of 2 readmissions per patient. In the United States, there are approximately 350,000 hospitalizations annually for adhesiolysis following gynecologic or abdominal surgery, which account for almost 1 million inpatient days at a cost of $2.3 billion. Even for patients without complications, adhesions originating from a previous surgery can present significant surgical challenges and additional morbidity risks in subsequent operations.
About Pioneer
Pioneer Pharma, founded in Hainan in 1996, imports and distributes high-end pharmaceutical products into China. Pioneer markets and distributes over 30 products across a wide range of therapeutic categories on behalf of its strategic partners and has filed over 10 additional products that are pending approval. The company has over 34 representative offices across China and covers over 7,500 hospitals and 40,000 drugstores.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx®, CollaFilm, DermaSil™, CollaPress™ and Liquicoll®. Approved products based on the Company's technologies include: Collatamp® G, Septocoll®, CollaGUARD, Collieva®, CollaCare®, Collexa®, Zorpreva™, and LidoColl®.
Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com.
CONTACT: Veronica Kelly, +353 9064 86834, vkelly@innocoll-pharma.com
SOURCE Innocoll, Inc.
Back to top
RELATED LINKS
http://www.innocollinc.com/
http://www.prnewswire.com/news-releases/innocoll-enters-partnership-with-pioneer-pharma-in-china-for-the-distribution-of-collaguard-132127138.html
Dr. Michael Myers, President and CEO stated "This is an exciting development for Innocoll. China is becoming an increasingly important and dynamic market for medical products and we are very pleased to have established this partnership with such an innovative company as Pioneer. I look forward to exploring additional partnership opportunities between our two companies."
Mr. XinZhou Li, President and CEO from Pioneer Pharma stated "We are very excited to have finally reached the partnership agreement with Innocoll. Let us mark this day with remembrance as CollaGUARD will become a very important product in our current distribution channel. We believe that CollaGUARD® has significant market potential and Pioneer will try to make it happen. "
About CollaGUARD®
CollaGUARD is a transparent bioresorbable film of 100% type I collagen developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P < 0.001) and significantly reduced the extent and severity of adhesions (P < 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
About Postoperative Adhesions
Postoperative adhesions are abnormal fibrous connections that can form between any apposing internal organ and serous membrane as a natural consequence of abdominopelvic surgery. Adhesions occur in almost 95% of laparotomies and may lead to serious complications such as intestinal obstruction, secondary female infertility, and chronic abdominal or pelvic pain. More than 30% of patients who undergo open gynecologic or general surgery are readmitted within 10 years for disorders that are considered directly or potentially related to adhesions, with an average of 2 readmissions per patient. In the United States, there are approximately 350,000 hospitalizations annually for adhesiolysis following gynecologic or abdominal surgery, which account for almost 1 million inpatient days at a cost of $2.3 billion. Even for patients without complications, adhesions originating from a previous surgery can present significant surgical challenges and additional morbidity risks in subsequent operations.
About Pioneer
Pioneer Pharma, founded in Hainan in 1996, imports and distributes high-end pharmaceutical products into China. Pioneer markets and distributes over 30 products across a wide range of therapeutic categories on behalf of its strategic partners and has filed over 10 additional products that are pending approval. The company has over 34 representative offices across China and covers over 7,500 hospitals and 40,000 drugstores.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx®, CollaFilm, DermaSil™, CollaPress™ and Liquicoll®. Approved products based on the Company's technologies include: Collatamp® G, Septocoll®, CollaGUARD, Collieva®, CollaCare®, Collexa®, Zorpreva™, and LidoColl®.
Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com.
CONTACT: Veronica Kelly, +353 9064 86834, vkelly@innocoll-pharma.com
SOURCE Innocoll, Inc.
Back to top
RELATED LINKS
http://www.innocollinc.com/
http://www.prnewswire.com/news-releases/innocoll-enters-partnership-with-pioneer-pharma-in-china-for-the-distribution-of-collaguard-132127138.html
Tuesday, November 08, 2011
Conservative Management of Mesh-Site Infection
Conservative Management of Mesh-Site Infection
in Hernia Repair
Brenda Aguilar, MD, Alyssa B. Chapital, MD,
James A. Madura, II, MD, and Kristi L. Harold, MD
JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES
Volume 20, Number 3, 2010
ª Mary Ann Liebert, Inc.
Abstract
Background: Mesh hernioplasty is the preferred surgical procedure for large abdominal wall hernias. Infection
remains one of the most challenging complications of this operation. Salvaging infected prosthetic material after
ventral hernia repair is rarely successful. Most cases require mesh excision and complex abdominal wall reconstruction,
with variable success rates. In this article, we report 3 cases of mesh salvage after laparoscopic
ventral herniorrhapy with a novel use of percutaneous drainage and antibiotic irrigation.
Results: Three patients developed infected seromas after laparoscopic ventral hernia repair. The fascial defect
of the first patient was repaired with a commercially available 20 18 cm polytetrafluoroethylene (PTFE) mesh.
A complex fluid collection developed the following month in the anterior abdominal wall overlying the patient’s
mesh. The cultures grew Staphylococcus aureus. The second patient had a 30 20 cm PTFE mesh placed, which
developed a fluid collection with Enterococcus faecalis and Escherichia coli. The third case underwent repair, using
a another commercially available 22 28 cm PTFE mesh. A fluid collection measuring 20 10 cm in the anterior
abdominal wall developed, growing Staphylococcus lugdunensis. In all 3 cases, a percutaneous drain was placed
within the fluid collection and long-term intravenous (i.v.) access was obtained. I.v. antibiotics were initiated. In
addition, gentamicin (80 mg) with 20mL of saline was infused through the drain 3 times a day. All patients have
remained free of clinical signs of infection following the completion of therapy.
Conclusions: Infected mesh after laparoscopic ventral herniorrhapy without systemic sepsis may be amenable to
nonoperative treatment. A conservative approach that includes percutaneous drainage followed by antibiotic
irrigation is a potential alternative to prosthetic removal in carefully selected patients. Further evaluation of this
technique is warranted to define the most appropriate management strategies for these patients.
Introduction
The placement of prosthetic biomaterials has become a
standard procedure during ventral hernia repair surgery.
Clinical evidence support lower recurrence rates as they
generate ‘‘tension-free’’ closure of hernia defects and provide a
permanent replacement for native fascia that frequently has
been weakened or removed by previous surgery. Reduction
of ventral hernia recurrence by 30%1–3 has been shown.
However, the lower recurrence rates come at the price of
mesh-related complications, including seromas, adhesions,
chronic severe pain, migration, and mesh-related infections.4,5
The exact incidence of mesh infections is difficult to obtain
due to the variable presentation period after surgery. Infections
can arise anywhere from 2 to 39 months6 following repair.
The incidence has been reported from 0.001 to 8%7–14
in the literature. While this appears relatively infrequent,
when compared with other device-related infections, the
clinical significance of this diagnosis portends a complex,9,10
extended course for both the patient and the surgeon.8,12
The rate of mesh infection is influenced considerably by
underlying comorbidity, immunosuppression, incision size,
obesity, history of previous hernia repair or wound infection,
and tobacco use.7–14 Unfortunately, patients with these same
risk factors are also likely to have a recurrent hernia, if the
prosthetic mesh is not utilized in the repair.8
Standard surgical practice has traditionally advocated the
removal of contaminated or exposed prosthetics. Unfortunately,
the removal of the prosthetic materials is often
technically difficult when there is good tissue incorporation
and can increase the risk of subsequent enterocutaneous fistula
formation.15 Achieving closure of the fascial defect after
mesh removal is not usually possible; therefore, a larger
ventral hernia than at the time of original repair may result.
Department of General Surgery, Mayo Clinic Hospital, Phoenix, Arizona.
JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES
Volume 20, Number 3, 2010
ª Mary Ann Liebert, Inc.
DOI: 10.1089=lap.2009.0274
249
These issues have generated interest in a successful, conservative
treatment algorithm that does not involve mesh removal.
13,14,16,17 In this article, we describe a novel approach to
manage the complex problem of infected prosthetic mesh
following laparoscopic ventral hernia repair (LVHR).
Materials and Methods
This study was conducted by the Department of Surgery at
Mayo Clinic Hospital (Phoenix, AZ). We report 3 cases of
mesh infection after laparoscopic hernia repair with a prosthetic
mesh. The infection was diagnosed by clinical evidence
of pain, redness, induration, fever, and purulent discharge on
aspiration. We attempted to treat these cases with a conservative
approach.
After ultrasonografic confirmation of a fluid collection
surrounding the prosthetic mesh, a computed tomography
(CT)-guided placement of a drain was perform in all cases.
The skin overlying the left abdomen was sterilely prepped,
then draped to infiltrate 1% lidocaine. An 18-gauge needle
was advanced into the fluid collection. Through the needle, an
Amplatz wire was placed in the collection, the tract was
dilated with a 6.8- and 10-Fr fascial dilator, followed by the
placement of a 10-Fr locking loop all-purpose drainage catheter
that was then placed into the fluid collection. Repeat CT
was performed, confirming appropriate placement. A specimen
was sent to the lab for microbiology analysis. The tube
was secured with the skin by using a 2-0 Prolene suture. The
catheter was left to external bulb suction. The patients and
their relatives were instructed to irrigate the catheter with
gentamicin (80 mg) in 20mL of normal saline, leaving the
solution in the cavity for 30 minutes and then returning the
drain to bulb suction. This was performed 3 times per day.
We chose gentamicin as the primary antibiotic for the irrigation
therapy for its properties as a bactericidal agent at low
concentrations and its known activity against Staphylococcus
spp. as well as gram-negative cocci. Local use of gentamicin
provides much higher concentrations at wound sites, so blood
concentrations remain low, thus preventing toxicity. Special
recognition has been given to the use of gentamicin for the
treatment of infected skin cysts and other skin abscesses,
when preceded by incision and drainage to permit adequate
contact between the drug and the infecting bacteria.7
Case 1
A 50-year-old female underwent a robotic bilateral ovarian
cystectomy, at which time she had an abdominal wall mesh
place for an umbilical hernia. This mesh became infected and
was removed. Six months following removal, an LVHR was
performed with a 20 18cm polytetrafluoroethylene (PTFE)
Gore DualMesh (Creative Technologies Worldwide, Flagstaff,
AZ) for a recurrent hernia. One month later, the patient
was found to have erythema over her abdominal wall as well
as an elevated white blood cell count.ACT scan demonstrated
a complex fluid collection in the anterior abdominal wall
overlying the patient’s mesh. Percutaneous drainage of the
abscess was then undertaken, where approximately 100mL of
purulent material was aspirated. A drain was left in place. The
cultures revealed Staphylococcus aureus sensitive to ampicillin
and sulbactam. Drain irrigation with gentamicin (80 mg) in
20mLof normal saline (NS) 3 times a day as well as 1 month of
intravenous (i.v.) antibiotics was initiated. The drain and
central line were then removed. There has been no clinical
evidence of recurrent infection at 18 months of follow-up.
Case 2
A 63-year-old male with end-stage liver disease secondary
to primary sclerosing cholangitis underwent an orthotopic
liver transplant and Roux-en-Y choledochojejunostomy performed
in 2005. He subsequently developed a large ventral
hernia, which was repaired laparoscopically with a 30 20cm
PTFE Gore DualMesh in September 2007. In January 2009, the
patient underwent a routine colonoscopy and developed
Enterococcus faecalis and Escherichia coli bacteremia. An abdominal
CT scan demonstrated a fluid collection posterior to
the abdominal mesh. At that time, an external drain was
placed to treat the infection with gentamicin flushes (80mg in
20mL of NS 3 times a day), as well as i.v. antibiotics through a
peripherally inserted central catheter (PICC line), including
ceftriaxone (2 g once-daily) and ampicillin (2 g 3 times a day).
After 1 month of treatment, there were no clinical signs of
infection. The drain and antibiotics were then discontinued.
He continues to have no sign of infection currently at 11
months of follow-up.
Case 3
A 41-year-old female underwent multiple cesarean sections,
followed by the development of a ventral hernia. This
was repaired 8 times with mesh placement, in most cases. On
one occasion, the mesh had to be removed secondary to infection.
We performed an LVHR with a 22 28 cm PTFE Gore
DualMesh.
The patient presented the following month with generalized
body aches, chills, and fever. An abdominal CT scan was
performed that demonstrated a large fluid collection in the
anterior abdominal wall measuring 20 10 cm. It was drained,
producing 450mL of fluid. A percutaneous drain and a
PICC line were placed. Cultures grew 1þ S. lugdunensis. I.v.
amipicillin and sulbactam as well as gentamicin irrigation
(80mg in 20mL of NS) through the drain 3 times a day was
initiated.
At the end of treatment, a follow-up CT scan performed on
her abdomen and pelvis demonstrated improvement of the
anterior fluid collection previously drained. There remained a
seroma posterior to the mesh that was 9 cm in size without
evidence of abscess features. An attempt to aspirate the seroma
was unsuccessful due to its depth. The patient was
placed on amoxicillin=clavulanate (875 mg) by mouth twicedaily
for an additional 3 weeks of antibiotic therapy. The
anterior drain remained in place during this time and was
removed after it produced less than 10mL of serous fluid
daily. At 13 months of follow-up, she has done well with no
signs of infection.
Discussion
Surgical-site infections continue to be a major source of
morbidity throughout the world, accounting for almost 40–
60%10,18 of all postoperative infectious complications. This
concern, along with the increased costs associated with extended
hospitalization and reparative treatment, justifies
efforts to identify patient populations at risk and optimize
preoperative preparation and perioperative care. In the past
250 AGUILAR ET AL.
few years, the hernia repair with alloplastic prothesis has
become the standard treatment due to lower rates of recurrence,
when compared with simple suture closure. However,
the implantation of synthetic materials are related with
wound-associated complications in up to one third of cases.5
Mesh-related infectious complications occur in up to 13.6%
and usually require recurrent surgical intervention.12 The
more common agents associated with mesh infection are
Staphylococcus species (spp.) (especially S. aureus), Streptococcus
spp. (including group B streptococci), gram-negative
bacteria (mainly Enterobacteriaceae), and anaerobic bacteria
(including Peptostreptococcus spp.).18–21 In a study of meshrelated
infections following ventral herniorrhaphies, 63% of
the microorganisms isolated were methicillin-resistant S. aureus
(MRSA). Rarely, mesh infections are caused by Candida
spp. or Mycobacterium spp.21
Various factors are predictive of prosthetic infections, such
as patient-related illness, including diabetes mellitus, malnutrition,
chronic obstructive pulmonary disease, tobacco
and=or alcohol use, medical therapy with steroids, renal
failure, and morbid obesity.5–10,12,17,18,21 These medical comorbidities
are associated with decreased perfusion of the
skin and subcutaneous (s.c.) tissues as well as immunosuppressive
attributes. Factors directly to the operation, such as
the choice of mesh material and type of surgical procedure,
are still the subject of critical debate. In a meta-analysis of 20
trials (5016 participants) of open versus open nonmesh repair
of groin hernias, it was shown that the rate of postoperative
complications, including infections, was similar in both procedures.
4 A similar clinical trial with 200 adult umbilical
hernia repairs with or without mesh showed no differences in
results between techniques, including infection rate.21 Korenkov
et al.,22 in a clinical, randomized trial of 160 patients
with simple or complex hernias that underwent either suture
repair, autodermal skin graft, or onlay polypropylene mesh
repair, found fewer infectious complications after suture repair
(9%) than after skin graft or mesh repair (18%) for simple
hernias and 23–35% for complex hernias. White et al.23 reported
that the use of a mesh and hernia defect >10 cm were
associated with significantly more wound complications
(44 versus 26%; P<0.05), especially a increased incidence
of seroma (21 versus 7%). They also reported that patients
undergoing mesh repair were more likely to receive antibiotics
(91 versus 71%) and have s.c. drains placed (57 versus
25%), compared to simple primary repair.
The traditional surgical management for infection after
hernia repair with prosthetic materials advocates that all infected
prosthetic materials must be removed, but this leads to
a high risk of hernia recurrence. Innovative studies aim to
provide evidence that a conservative approach may be a
suitable alternative. Carbonell et al.26 studied hernia repairs
by using seven prosthetic mesh biomaterials innoculated with
bacteria in a live animal and concluded that ePTFE was the
least susceptible to infection, and with silver=chlorhexidine
coating, the prosthesis was able to kill all the inoculated
bacteria. Silver-chlorhexidine-impregnated meshes may be
the prosthetics of choice to prevent the occurrence of mesh
infection in LVHR. The literature would support that the
debridement of all purulent material and necrotic tissue is
essential, but it remains debatable whether to remove the
prostheses. Irrigation with antimicrobial solutions has been
attempted in a few trials. Trunzo et al.13 reported 2 cases of
infected seroma after laparoscopic ventral repair: A 20 23 cm
Parietex composite polyester mesh was used in 1 patient,
and a 32 33 cm piece of expanded PTFE was used in the
other. After the infections were diagnosed, the patients were
treated by abscess drainage, parenteral antibiotics, and 4
weeks of gentamicin irrigation (80mg in 30mL of solution)
via a drain 3 times per day. Both patients remained free of
clinical signs of infection at 12 and 16 months, respectively.
Ahmad et al.14 described 13 cases of open ventral hernia repair
with using polypropylene mesh resulting in infection.
They treated their patients with local management, including
incision, drainage, and debridement of the wound, followed
by irrigation with saline=povidone iodine. Eight patients
(62%) required daily dressing changes and five to seven debridements.
Three patients (23%) developed severe sepsis and
complete dehiscence of the wound. These patients averaged
10–12 debridements during recovery. Two patients (15%)
with cellulitis were discharged after 10–12 days with full recovery.
All the patients were followed for 3 months and did
not have recurrence of infection.
Some researchers believe that an individualized approach
is necessary to treat patients with mesh infections, and special
considerations must be taken regarding the type of mesh.27
The use of a multifilament polyester mesh is related to a
higher incidence of infection, small-bowel obstruction, and
enterocutaneous fistula formation than the use of other types
of mesh (e.g., knitted monofilament polypropylene, PTFE, or
woven polypropylene).2,12,19,17 Further, experimental studies
in animals relate the use of microporous mesh to a higher rate
of infections and development of seromas, whereas macroporous
material was shown to be associated with a higher
incidence of adhesive and erosive events.23–25 The ePTFE
mesh has generated conflicting theories as to its ability to be
salvaged in the face of infection. Paton et al.27 concluded that
patients with limited ePTFE mesh infections could be treated
with abscess drainage, antibiotics, and local wound care, but
more extensive infections require mesh removal. Petersen
et al.12 concluded that in their experience with 8 mesh-infected
cases, adequate drainage seemed to be sufficient for polypropylene
or polyester meshes; however, infected ePTFE
patches should be removed early. The researchers explained
that the structural matrix of ePTFE permits fluid retention and
bacterial growth due to inadecuate leucocyte invasion
through the 10-mm pores. Bellon et al.29,30 demonstrated that
S. aureus colonies produce alterations in the structure of
ePTFE. From using electron microscopy, they demonstrated
the deformation of internodal filaments and the creation of
fissures in the ePTFE microstructure, and that alteration of the
biomaterial facilitated the attachment and invasion of bacteria.
Despite these findings, we have had success with the
salvage of ePTFE after laparoscopic ventral hernia repair. In
our experience, infection of ePTFE does not always mandate
removal. Our 3 cases were successfully managed with
drainage, parenteral antibiotics, and gentamicin irrigation
through a drain, with no recurrence of infection.
Conclusions
For patients with an infected mesh in the absence of systemic
sepsis, a conservative approach that includes percutaneous
drainage, followed by antibiotic irrigation, is a potential
alternative to prosthetic removal. Further evaluation of this
MESH-SITE INFECTION 251
technique is warranted to define the most appropriate management
strategies for these patients.
Disclosure Statement
No competing financial interests exist.
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of infections of polytetrafluoroethylene-based mesh.
Surg Infect 2007;8:337–341.
28. Bellon JM, Bujan J, Contreras L, et al. Macrophage response
to experimental implantation of polypropylene protheses.
Eur Surg Res 1994;26:46–53.
29. Bleichrodt RP, Simmermacher RK, Van der Lei B,
Schakenraad JM. Expanded polytetrafluoroethylene patch
versus polypropylene mesh for the repair of contaminated
defects of the abdominal wall. Surg Gynecol Obstet 1993;
176:18–24.
30. Bellon JM, Contreras LA, Bujan J. Effect of relaparotomy
through previously integrated polypropylene and polytetrafluoroethylene
experimental implants in the abdominal
wall. J Am Coll Surg 1999;188:466–472.
31. Bellon JM, Jurado F, Carranza A. In vitro interaction of
bacteria with polypropylene=ePTFEprostheses. Biomaterials
2001;22:2021–2024.
Address correspondence to:
Brenda Aguilar, MD
Department of General Surgery
Mayo Clinic Hospital
5777 East Mayo Boulevard
Phoenix, AZ 85054
E-mail: Aguilar.Brenda@mayo.edu
in Hernia Repair
Brenda Aguilar, MD, Alyssa B. Chapital, MD,
James A. Madura, II, MD, and Kristi L. Harold, MD
JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES
Volume 20, Number 3, 2010
ª Mary Ann Liebert, Inc.
Abstract
Background: Mesh hernioplasty is the preferred surgical procedure for large abdominal wall hernias. Infection
remains one of the most challenging complications of this operation. Salvaging infected prosthetic material after
ventral hernia repair is rarely successful. Most cases require mesh excision and complex abdominal wall reconstruction,
with variable success rates. In this article, we report 3 cases of mesh salvage after laparoscopic
ventral herniorrhapy with a novel use of percutaneous drainage and antibiotic irrigation.
Results: Three patients developed infected seromas after laparoscopic ventral hernia repair. The fascial defect
of the first patient was repaired with a commercially available 20 18 cm polytetrafluoroethylene (PTFE) mesh.
A complex fluid collection developed the following month in the anterior abdominal wall overlying the patient’s
mesh. The cultures grew Staphylococcus aureus. The second patient had a 30 20 cm PTFE mesh placed, which
developed a fluid collection with Enterococcus faecalis and Escherichia coli. The third case underwent repair, using
a another commercially available 22 28 cm PTFE mesh. A fluid collection measuring 20 10 cm in the anterior
abdominal wall developed, growing Staphylococcus lugdunensis. In all 3 cases, a percutaneous drain was placed
within the fluid collection and long-term intravenous (i.v.) access was obtained. I.v. antibiotics were initiated. In
addition, gentamicin (80 mg) with 20mL of saline was infused through the drain 3 times a day. All patients have
remained free of clinical signs of infection following the completion of therapy.
Conclusions: Infected mesh after laparoscopic ventral herniorrhapy without systemic sepsis may be amenable to
nonoperative treatment. A conservative approach that includes percutaneous drainage followed by antibiotic
irrigation is a potential alternative to prosthetic removal in carefully selected patients. Further evaluation of this
technique is warranted to define the most appropriate management strategies for these patients.
Introduction
The placement of prosthetic biomaterials has become a
standard procedure during ventral hernia repair surgery.
Clinical evidence support lower recurrence rates as they
generate ‘‘tension-free’’ closure of hernia defects and provide a
permanent replacement for native fascia that frequently has
been weakened or removed by previous surgery. Reduction
of ventral hernia recurrence by 30%1–3 has been shown.
However, the lower recurrence rates come at the price of
mesh-related complications, including seromas, adhesions,
chronic severe pain, migration, and mesh-related infections.4,5
The exact incidence of mesh infections is difficult to obtain
due to the variable presentation period after surgery. Infections
can arise anywhere from 2 to 39 months6 following repair.
The incidence has been reported from 0.001 to 8%7–14
in the literature. While this appears relatively infrequent,
when compared with other device-related infections, the
clinical significance of this diagnosis portends a complex,9,10
extended course for both the patient and the surgeon.8,12
The rate of mesh infection is influenced considerably by
underlying comorbidity, immunosuppression, incision size,
obesity, history of previous hernia repair or wound infection,
and tobacco use.7–14 Unfortunately, patients with these same
risk factors are also likely to have a recurrent hernia, if the
prosthetic mesh is not utilized in the repair.8
Standard surgical practice has traditionally advocated the
removal of contaminated or exposed prosthetics. Unfortunately,
the removal of the prosthetic materials is often
technically difficult when there is good tissue incorporation
and can increase the risk of subsequent enterocutaneous fistula
formation.15 Achieving closure of the fascial defect after
mesh removal is not usually possible; therefore, a larger
ventral hernia than at the time of original repair may result.
Department of General Surgery, Mayo Clinic Hospital, Phoenix, Arizona.
JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES
Volume 20, Number 3, 2010
ª Mary Ann Liebert, Inc.
DOI: 10.1089=lap.2009.0274
249
These issues have generated interest in a successful, conservative
treatment algorithm that does not involve mesh removal.
13,14,16,17 In this article, we describe a novel approach to
manage the complex problem of infected prosthetic mesh
following laparoscopic ventral hernia repair (LVHR).
Materials and Methods
This study was conducted by the Department of Surgery at
Mayo Clinic Hospital (Phoenix, AZ). We report 3 cases of
mesh infection after laparoscopic hernia repair with a prosthetic
mesh. The infection was diagnosed by clinical evidence
of pain, redness, induration, fever, and purulent discharge on
aspiration. We attempted to treat these cases with a conservative
approach.
After ultrasonografic confirmation of a fluid collection
surrounding the prosthetic mesh, a computed tomography
(CT)-guided placement of a drain was perform in all cases.
The skin overlying the left abdomen was sterilely prepped,
then draped to infiltrate 1% lidocaine. An 18-gauge needle
was advanced into the fluid collection. Through the needle, an
Amplatz wire was placed in the collection, the tract was
dilated with a 6.8- and 10-Fr fascial dilator, followed by the
placement of a 10-Fr locking loop all-purpose drainage catheter
that was then placed into the fluid collection. Repeat CT
was performed, confirming appropriate placement. A specimen
was sent to the lab for microbiology analysis. The tube
was secured with the skin by using a 2-0 Prolene suture. The
catheter was left to external bulb suction. The patients and
their relatives were instructed to irrigate the catheter with
gentamicin (80 mg) in 20mL of normal saline, leaving the
solution in the cavity for 30 minutes and then returning the
drain to bulb suction. This was performed 3 times per day.
We chose gentamicin as the primary antibiotic for the irrigation
therapy for its properties as a bactericidal agent at low
concentrations and its known activity against Staphylococcus
spp. as well as gram-negative cocci. Local use of gentamicin
provides much higher concentrations at wound sites, so blood
concentrations remain low, thus preventing toxicity. Special
recognition has been given to the use of gentamicin for the
treatment of infected skin cysts and other skin abscesses,
when preceded by incision and drainage to permit adequate
contact between the drug and the infecting bacteria.7
Case 1
A 50-year-old female underwent a robotic bilateral ovarian
cystectomy, at which time she had an abdominal wall mesh
place for an umbilical hernia. This mesh became infected and
was removed. Six months following removal, an LVHR was
performed with a 20 18cm polytetrafluoroethylene (PTFE)
Gore DualMesh (Creative Technologies Worldwide, Flagstaff,
AZ) for a recurrent hernia. One month later, the patient
was found to have erythema over her abdominal wall as well
as an elevated white blood cell count.ACT scan demonstrated
a complex fluid collection in the anterior abdominal wall
overlying the patient’s mesh. Percutaneous drainage of the
abscess was then undertaken, where approximately 100mL of
purulent material was aspirated. A drain was left in place. The
cultures revealed Staphylococcus aureus sensitive to ampicillin
and sulbactam. Drain irrigation with gentamicin (80 mg) in
20mLof normal saline (NS) 3 times a day as well as 1 month of
intravenous (i.v.) antibiotics was initiated. The drain and
central line were then removed. There has been no clinical
evidence of recurrent infection at 18 months of follow-up.
Case 2
A 63-year-old male with end-stage liver disease secondary
to primary sclerosing cholangitis underwent an orthotopic
liver transplant and Roux-en-Y choledochojejunostomy performed
in 2005. He subsequently developed a large ventral
hernia, which was repaired laparoscopically with a 30 20cm
PTFE Gore DualMesh in September 2007. In January 2009, the
patient underwent a routine colonoscopy and developed
Enterococcus faecalis and Escherichia coli bacteremia. An abdominal
CT scan demonstrated a fluid collection posterior to
the abdominal mesh. At that time, an external drain was
placed to treat the infection with gentamicin flushes (80mg in
20mL of NS 3 times a day), as well as i.v. antibiotics through a
peripherally inserted central catheter (PICC line), including
ceftriaxone (2 g once-daily) and ampicillin (2 g 3 times a day).
After 1 month of treatment, there were no clinical signs of
infection. The drain and antibiotics were then discontinued.
He continues to have no sign of infection currently at 11
months of follow-up.
Case 3
A 41-year-old female underwent multiple cesarean sections,
followed by the development of a ventral hernia. This
was repaired 8 times with mesh placement, in most cases. On
one occasion, the mesh had to be removed secondary to infection.
We performed an LVHR with a 22 28 cm PTFE Gore
DualMesh.
The patient presented the following month with generalized
body aches, chills, and fever. An abdominal CT scan was
performed that demonstrated a large fluid collection in the
anterior abdominal wall measuring 20 10 cm. It was drained,
producing 450mL of fluid. A percutaneous drain and a
PICC line were placed. Cultures grew 1þ S. lugdunensis. I.v.
amipicillin and sulbactam as well as gentamicin irrigation
(80mg in 20mL of NS) through the drain 3 times a day was
initiated.
At the end of treatment, a follow-up CT scan performed on
her abdomen and pelvis demonstrated improvement of the
anterior fluid collection previously drained. There remained a
seroma posterior to the mesh that was 9 cm in size without
evidence of abscess features. An attempt to aspirate the seroma
was unsuccessful due to its depth. The patient was
placed on amoxicillin=clavulanate (875 mg) by mouth twicedaily
for an additional 3 weeks of antibiotic therapy. The
anterior drain remained in place during this time and was
removed after it produced less than 10mL of serous fluid
daily. At 13 months of follow-up, she has done well with no
signs of infection.
Discussion
Surgical-site infections continue to be a major source of
morbidity throughout the world, accounting for almost 40–
60%10,18 of all postoperative infectious complications. This
concern, along with the increased costs associated with extended
hospitalization and reparative treatment, justifies
efforts to identify patient populations at risk and optimize
preoperative preparation and perioperative care. In the past
250 AGUILAR ET AL.
few years, the hernia repair with alloplastic prothesis has
become the standard treatment due to lower rates of recurrence,
when compared with simple suture closure. However,
the implantation of synthetic materials are related with
wound-associated complications in up to one third of cases.5
Mesh-related infectious complications occur in up to 13.6%
and usually require recurrent surgical intervention.12 The
more common agents associated with mesh infection are
Staphylococcus species (spp.) (especially S. aureus), Streptococcus
spp. (including group B streptococci), gram-negative
bacteria (mainly Enterobacteriaceae), and anaerobic bacteria
(including Peptostreptococcus spp.).18–21 In a study of meshrelated
infections following ventral herniorrhaphies, 63% of
the microorganisms isolated were methicillin-resistant S. aureus
(MRSA). Rarely, mesh infections are caused by Candida
spp. or Mycobacterium spp.21
Various factors are predictive of prosthetic infections, such
as patient-related illness, including diabetes mellitus, malnutrition,
chronic obstructive pulmonary disease, tobacco
and=or alcohol use, medical therapy with steroids, renal
failure, and morbid obesity.5–10,12,17,18,21 These medical comorbidities
are associated with decreased perfusion of the
skin and subcutaneous (s.c.) tissues as well as immunosuppressive
attributes. Factors directly to the operation, such as
the choice of mesh material and type of surgical procedure,
are still the subject of critical debate. In a meta-analysis of 20
trials (5016 participants) of open versus open nonmesh repair
of groin hernias, it was shown that the rate of postoperative
complications, including infections, was similar in both procedures.
4 A similar clinical trial with 200 adult umbilical
hernia repairs with or without mesh showed no differences in
results between techniques, including infection rate.21 Korenkov
et al.,22 in a clinical, randomized trial of 160 patients
with simple or complex hernias that underwent either suture
repair, autodermal skin graft, or onlay polypropylene mesh
repair, found fewer infectious complications after suture repair
(9%) than after skin graft or mesh repair (18%) for simple
hernias and 23–35% for complex hernias. White et al.23 reported
that the use of a mesh and hernia defect >10 cm were
associated with significantly more wound complications
(44 versus 26%; P<0.05), especially a increased incidence
of seroma (21 versus 7%). They also reported that patients
undergoing mesh repair were more likely to receive antibiotics
(91 versus 71%) and have s.c. drains placed (57 versus
25%), compared to simple primary repair.
The traditional surgical management for infection after
hernia repair with prosthetic materials advocates that all infected
prosthetic materials must be removed, but this leads to
a high risk of hernia recurrence. Innovative studies aim to
provide evidence that a conservative approach may be a
suitable alternative. Carbonell et al.26 studied hernia repairs
by using seven prosthetic mesh biomaterials innoculated with
bacteria in a live animal and concluded that ePTFE was the
least susceptible to infection, and with silver=chlorhexidine
coating, the prosthesis was able to kill all the inoculated
bacteria. Silver-chlorhexidine-impregnated meshes may be
the prosthetics of choice to prevent the occurrence of mesh
infection in LVHR. The literature would support that the
debridement of all purulent material and necrotic tissue is
essential, but it remains debatable whether to remove the
prostheses. Irrigation with antimicrobial solutions has been
attempted in a few trials. Trunzo et al.13 reported 2 cases of
infected seroma after laparoscopic ventral repair: A 20 23 cm
Parietex composite polyester mesh was used in 1 patient,
and a 32 33 cm piece of expanded PTFE was used in the
other. After the infections were diagnosed, the patients were
treated by abscess drainage, parenteral antibiotics, and 4
weeks of gentamicin irrigation (80mg in 30mL of solution)
via a drain 3 times per day. Both patients remained free of
clinical signs of infection at 12 and 16 months, respectively.
Ahmad et al.14 described 13 cases of open ventral hernia repair
with using polypropylene mesh resulting in infection.
They treated their patients with local management, including
incision, drainage, and debridement of the wound, followed
by irrigation with saline=povidone iodine. Eight patients
(62%) required daily dressing changes and five to seven debridements.
Three patients (23%) developed severe sepsis and
complete dehiscence of the wound. These patients averaged
10–12 debridements during recovery. Two patients (15%)
with cellulitis were discharged after 10–12 days with full recovery.
All the patients were followed for 3 months and did
not have recurrence of infection.
Some researchers believe that an individualized approach
is necessary to treat patients with mesh infections, and special
considerations must be taken regarding the type of mesh.27
The use of a multifilament polyester mesh is related to a
higher incidence of infection, small-bowel obstruction, and
enterocutaneous fistula formation than the use of other types
of mesh (e.g., knitted monofilament polypropylene, PTFE, or
woven polypropylene).2,12,19,17 Further, experimental studies
in animals relate the use of microporous mesh to a higher rate
of infections and development of seromas, whereas macroporous
material was shown to be associated with a higher
incidence of adhesive and erosive events.23–25 The ePTFE
mesh has generated conflicting theories as to its ability to be
salvaged in the face of infection. Paton et al.27 concluded that
patients with limited ePTFE mesh infections could be treated
with abscess drainage, antibiotics, and local wound care, but
more extensive infections require mesh removal. Petersen
et al.12 concluded that in their experience with 8 mesh-infected
cases, adequate drainage seemed to be sufficient for polypropylene
or polyester meshes; however, infected ePTFE
patches should be removed early. The researchers explained
that the structural matrix of ePTFE permits fluid retention and
bacterial growth due to inadecuate leucocyte invasion
through the 10-mm pores. Bellon et al.29,30 demonstrated that
S. aureus colonies produce alterations in the structure of
ePTFE. From using electron microscopy, they demonstrated
the deformation of internodal filaments and the creation of
fissures in the ePTFE microstructure, and that alteration of the
biomaterial facilitated the attachment and invasion of bacteria.
Despite these findings, we have had success with the
salvage of ePTFE after laparoscopic ventral hernia repair. In
our experience, infection of ePTFE does not always mandate
removal. Our 3 cases were successfully managed with
drainage, parenteral antibiotics, and gentamicin irrigation
through a drain, with no recurrence of infection.
Conclusions
For patients with an infected mesh in the absence of systemic
sepsis, a conservative approach that includes percutaneous
drainage, followed by antibiotic irrigation, is a potential
alternative to prosthetic removal. Further evaluation of this
MESH-SITE INFECTION 251
technique is warranted to define the most appropriate management
strategies for these patients.
Disclosure Statement
No competing financial interests exist.
References
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2. Leber GE, Garb JL, Alexander AI, Reed WP. Long-term
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3. Vrijland WW, Van den Tol MP, Luijendijk RW et al. Randomized,
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4. Grant AM. Open mesh versus nonmesh repair of groin
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9. Bliziotis IA, Kasiakou SK, Kapaskelis AM, Falagas ME.
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10. Paton BL, Novitsky Y, Zerey M, et al. Management of infections
of polytetrafluoroethylene-based mesh. Surg Infect
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11. Praveen S, Rohaizak M. Local antibiotics are equivalent
to intravenous antibiotics in the prevention of superficial
wound infection in inguinal hernioplasty. Asian J Surg 2009;
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12. Petersen S, Henke G, Freitag M, et al. Deep prosthesis infection
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clinical outcome. Eur J Surg 2001;167:453–457.
13. Trunzo JA, Ponsky JL, Jin J, et al. A novel approach for
salvaging infected prosthetic mesh after ventral hernia repair.
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14. Ahmad S, Mufti TS, Zafar A, Akbar I. Conservative managment
of mesh-site infection in ventral hernia repair. Ayub
Med Coll Abbottabad 2007;19:75–77.
15. Fawole AS, Chaparala RP, Ambrose NS. Fate of the inguinal
hernia following removal of infected prosthetic mesh. Hernia
2006;10:58–61.
16. Luijendijk RW, Hop WC, Van den Tol MP, et al. A comparison
of suture repair with mesh repair for incisional
hernia. NEJM 2000;343:392–398.
17. Stoppa RE. The treatment of complicated groin and incisional
hernias. World J Surg 1989;13:545–554.
18. Malone DL, Genuit T, Tracy JK, et al. Surgical site infections:
Reanalysis of risk factors. J Surg Res 2002;103:89–95.
19. Demiter S, Gecim IE, Aydinuraz K, et al. Affinity of Staphylococcus
epidermidis to various prosthetic graft materials.
J Surg Res 2001;99:70–74.
20. Cobb WS, Harris JB, Lokey JS, McGill ES, et al. Incisional
herniorrhaphy with intraperitoneal composite mesh: A report
of 95 cases. Am Surg 2003;69:784–787.
21. Arroyo A,Garcia P, Perez F, et al. Randomized, clinical trial
comparing suture and mesh repair of umbilical hernia in
adults. Br J Surg 2001;88:1321–1323.
22. Korenkov M, Sauerland S, Arndt M, Bograd L, Neugebauer
EA, Troidl H. Randomized, clinical trial of suture repair,
polypropylene mesh, or autodermal hernioplasty for incisional
hernia. Br J Surg 2002;89:50–56.
23. White TJ, Santos MC, Thompson JS. Factors affecting wound
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24. Amid PK. Classification of biomaterials and their related
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25. Zheng F, Xu L, Verbiest L, et al. Cytokine production following
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2005;19:430–443.
27. Paton LB, Novitsky YW, Zerey M, Sing RF, et al. Management
of infections of polytetrafluoroethylene-based mesh.
Surg Infect 2007;8:337–341.
28. Bellon JM, Bujan J, Contreras L, et al. Macrophage response
to experimental implantation of polypropylene protheses.
Eur Surg Res 1994;26:46–53.
29. Bleichrodt RP, Simmermacher RK, Van der Lei B,
Schakenraad JM. Expanded polytetrafluoroethylene patch
versus polypropylene mesh for the repair of contaminated
defects of the abdominal wall. Surg Gynecol Obstet 1993;
176:18–24.
30. Bellon JM, Contreras LA, Bujan J. Effect of relaparotomy
through previously integrated polypropylene and polytetrafluoroethylene
experimental implants in the abdominal
wall. J Am Coll Surg 1999;188:466–472.
31. Bellon JM, Jurado F, Carranza A. In vitro interaction of
bacteria with polypropylene=ePTFEprostheses. Biomaterials
2001;22:2021–2024.
Address correspondence to:
Brenda Aguilar, MD
Department of General Surgery
Mayo Clinic Hospital
5777 East Mayo Boulevard
Phoenix, AZ 85054
E-mail: Aguilar.Brenda@mayo.edu
Diagnosis and management of chronic radiation enteritis
Diagnosis and management of chronic radiation enteritis
http://www.aboutcancer.com/radiation_enteritis_utd_807.htm
INTRODUCTION — Chronic radiation enteritis is a complication of radiation therapy for cancer, most commonly for rectal, prostate and pelvic malignancies. It can affect both the large and small intestine, is often progressive, and may lead to a variety of clinical consequences (such as diarrhea, nausea, weight loss, abdominal pain, intestinal obstruction, and perforation) depending upon the extent of the injury. It usually develops six or more months after radiation therapy (mean approximately 5 years, range two months to as long as 30 years. This contrasts with the timing of acute radiation enteritis (characterized by diarrhea and abdominal pain), which develops during or shortly after radiation therapy and resolves within two to six weeks.
The incidence has not been well defined, in part because of the large number of patients who died or were lost to follow-up in major studies involving radiation therapy, and because of the variability in the field size and dose of radiation. One literature review estimated that the incidence ranged from 1.2 to as high as 15 percent in patients with rectal cancer
This topic review will focus on the diagnosis and management of chronic radiation injury to the small intestines and proximal colon. Issues related to the prevention and treatment of chronic radiation proctitis (usually encountered following treatment of cancers of the rectum, cervix, uterus, prostate, urinary bladder, and testes) are presented separately.
PATHOGENESIS — Chronic radiation enteritis usually develops only after large doses of radiation therapy have been delivered (4500 to 5500 cGY); it is uncommon at lower doses. In addition to the dose of radiation, several other predisposing conditions have been described including:
Older age
Combined chemotherapy
Poor radiation technique
Postoperative radiation; in this setting, bowel loops fixed together by adhesions may prolapse into the pelvis, leading them to receive excessive radiation exposure. Adhesions due to past surgical procedures can have the same effect.
Intestinal injury is believed to be related to oxidative damage caused by the formation of free radicals. The end result is an obliterative endarteritis that leads to intestinal ischemia resulting in stricturing with ulceration and fibrosis and occasionally fistula formation. The physiologic consequences may include altered intestinal transit, reduced bile acid absorption, increased intestinal permeability, bacterial overgrowth and lactose malabsorption The resulting clinical manifestations may include nausea, vomiting, lactose intolerance, obstructive symptoms, diarrhea, weight loss, malnutrition, and bleeding (usually in patients with colonic involvement).
The prominent histopathologic features are those of an occlusive vasculitis with diffuse collagen deposition and fibrosis. The arteriolar walls may show a hyaline ring-like thickening and large foams cells beneath the intima. Mucosal ulceration, necrosis and perforation may develop as the disease progresses. Progressive fibrosis leads to stricturing with dilation of proximal segments. The intestinal segments and their associated serosa appear grossly thickened. Telangiectasias may be seen.
The precise mechanisms leading from oxidative damage to the histologic and morphologic abnormalities described above are incompletely understood. Several theories have been proposed, all of which are probably interrelated:
One model suggests that fibrosis develops from the initial mucosal injury
Another theory suggests that fibrosis develops in connective tissues where radiation has caused a decrease in cell turnover and a low rate of proliferation.
A third model focuses on the cellular responses to vascular damage caused by paracrine mediators. The signals leading to the developing of fibrosis are a topic of intensive ongoing investigation.
One study found that intestinal webs forming after radiation therapy demonstrated an impaired vasodilatory response in vitro to acetylcholine treatment. This microvascular dysfunction may lead to the formation of the abnormal tissue response seen in the wall of the intestine post-radiation therapy.
CLINICAL MANIFESTATIONS — The classical features of radiation enteritis are abdominal pain, nausea, vomiting, and diarrhea. Patients with severe disease may develop intermittent, partial, or complete small bowel obstruction
As noted above, bacterial overgrowth may lead to malabsorption and contribute to the nausea, abdominal pain and diarrhea. Bacterial overgrowth should be suspected in patients with intestinal strictures. Another clue may be the development of new lactose intolerance. Nonspecific symptoms include diarrhea, bloating, excessive gas, borborygmi, and nausea. Most such patients have only subtle laboratory or clinical findings pointing toward the diagnosis; thus a high index of suspicion is required. Rare patients with severe malabsorption may present with a more fulminant clinical and laboratory profile
DIAGNOSIS — The diagnosis is usually established by suggestive radiologic findings in patients with compatible clinical features who have a history of prior radiation exposure. The patient's previous radiation treatment record should be reviewed to determine the total dose and distribution of the radiation field. This may help to determine which intestinal segments may have received excessive radiation exposure, information that can be correlated with the radiologic findings and the clinical presentation.
We usually obtain an abdominal CT scan followed by an upper gastrointestinal series with small bowel follow through in patients with suspected small bowel disease. Additional imaging is reserved for patients in whom the diagnosis remains unclear. We generally perform a colonoscopy in patients with suspected colonic involvement.
Upper gastrointestinal series — An upper gastrointestinal series with small bowel follow-through is a useful initial test for evaluating the extent of disease although it is not as sensitive as enteroclysis.
Enteroclysis — Enteroclysis involves the instillation of contrast material (usually administered through a nasoenteric tube) into the small bowel using a pump (making it considerably less comfortable than a standard small bowel follow-through). It provides more detailed visualization of the small bowel compared with a standard upper gastrointestinal series. Suggestive findings include submucosal thickening, single or multiple stenoses, adhesions, and sinus or fistula formation. Its sensitivity and specificity for radiation enteritis have not been well-defined.
CT scan — Computed tomography may show thickening of bowel segments, but the findings are nonspecific. CT may be helpful in narrowing the differential diagnosis, particularly in distinguishing strictures due to radiation enteritis from those arising from abdominal metastases or a local recurrence
CT enteroclysis (in which a CT is performed after instilling contrast into the intestine using a nasoenteric tube) produces superior bowel opacification compared with conventional CT, and may therefore be useful for identifying low-grade or intermittent obstruction (reported sensitivity and specificity of approximately 88 and 82 percent, respectively). However, the technique is still used only in a few specialized centers. Similarly, other improvements in CT imaging of the small bowel (such as three-dimensional imaging) will likely also have a role in diagnosis of radiation enteritis but are not yet widely available
Magnetic resonance enteroclysis — Magnetic resonance enteroclysis permits visualization of the small bowel using similar principles as described above for CT enteroclysis. Initial studies suggest the results are comparable to (and possibly more sensitive than) CT enteroclysis. However, only small numbers of patients have been studied and the technique is not yet widely available.
Enteroscopy — Enteroscopy (peroral endoscopy of the small bowel using specialized endoscopes) has a limited role in the diagnosis of radiation enteritis although it may help to narrow the differential diagnosis. Enteroclysis can be performed following enteroscopy by leaving a tube inserted in the intestine upon withdrawal of the enteroscope.
Capsule endoscopy — There is no published experience with capsule endoscopy specifically for diagnosing radiation enteritis, although there is some clinical experience. However, it should probably not be performed in patients in whom there is a strong clinical suspicion for radiation enteritis because the capsule may become lodged in a strictured segment, requiring surgical removal.
Colonoscopy — Colonoscopy is helpful in evaluating colonic involvement and can also visualize the terminal ileum. Mucosal features consistent with radiation injury include pallor with friability and telangiectasias, which can be multiple, large, and serpiginous; these changes tend to be continuous. Although mucosal biopsies are not diagnostic, they can help to exclude other causes of proctitis such as infection or inflammatory bowel disease.
DIFFERENTIAL DIAGNOSIS — The differential diagnosis of chronic radiation enteritis is broad. Other diagnostic possibilities include post-surgical adhesions, malabsorption syndromes, abdominal metastases, lymphoma, Crohn's disease, infectious, ischemic or ulcerative colitis, and intestinal pseudo-obstruction.
MEDICAL MANAGEMENT — Prevention is the key to avoiding chronic radiation enteritis. Once established, treatment should be as conservative as possible focusing on relief of symptoms. Experience with specific medical treatments has been derived largely from small clinical trials and case series. Approaches used to treat small bowel disease will be summarized below while specific treatments aimed at radiation proctitis are discussed separately.
Dietary recommendations — There does not appear to be a clear-cut diet that reliably alleviates symptoms. A high fiber diet should probably not be recommended specifically since it may worsen diarrhea and urgency. Some patients may develop lactose intolerance, which may be due to bacterial overgrowth, and may improve following antibiotic treatment (see below). Others may require avoidance of lactose. Enteral formulas supplemented with glutamine may have a benefit but studies are limited
Antidiarrheal agents — Judicious use of antidiarrheal agents (such as loperamide) can help improve diarrhea, although it should not be used in patients with suspected small or large bowel obstruction. The efficacy of loperamide was evaluated in a crossover trial involving 18 patients with diarrhea due to radiation enteritis who were randomly assigned to loperamide or placebo for 14 days separated by a 14 day washout period. Loperamide was associated with a significant reduction in the frequency of bowel movements, slower intestinal transit, and improvement in the absorption of bile acids.
Antibiotics — Antibiotics may reduce symptoms in patients in whom bacterial overgrowth has developed. Specific testing for bacterial overgrowth is preferable to empiric therapy. A major drawback to empiric therapy is that treatment may require more than one antibiotic, and repeated and sometimes cyclic treatment. Because antibiotics may be associated with adverse effects, some of which may mimic symptoms of bacterial overgrowth (such as diarrhea and abdominal discomfort), establishing a firm diagnosis is important. This can usually be accomplished with a breath test.
5-ASA drugs — A case report (published nearly three decades ago) suggested a possible benefit from sulfasalazine with or without oral prednisone. There is no large published experience with either of these drugs. Discordant results have been obtained from controlled clinical trials evaluating mesalazine or sulfasalazine in the prevention of acute radiation enteritis
Hyperbaric oxygen — HBO has been used for treatment of refractory foot ulcers in diabetes and in other conditions [39]. The theoretical benefit of hyperbaric oxygen therapy (HBO) may be via inhibition of bacterial growth [40], preservation of marginally perfused tissue, and inhibition of toxin production [41].
A benefit in chronic radiation enteritis was suggested in a case report of a patient in whom 20 treatments over a one month period brought about objective improvements in symptoms and absorption of D-xylose. However, this anecdote did not give the results of long-term follow-up. Other reports have also suggested a benefit for patients with chronic radiation proctitis.
The equipment needed for hyperbaric oxygen treatment is expensive and not widely available. Thus, at the present time, it is not a practical means of treating chronic radiation enteritis outside of centers specializing in this approach, particularly since its effectiveness has not been well-studied.
Parenteral nutrition — A mainstay of the medical therapy of severe chronic radiation enteritis has been total parenteral nutrition (TPN), the success of which is similar for other intestinal disorders requiring TPN. One of the largest series included 54 patients who required home TPN mostly because of intestinal obstruction (27 patients), short bowel syndrome (17 patients), malabsorption (five patients), fistula formation (three patients), and dysmotility (two patients). TPN was initiated a median of 20 months after radiation therapy and was administered for a median of 20 months. Cumulative 5-year survival was 64 percent. Most early deaths were due to recurrent cancer. Similar survival estimates were reached in other series .
SURGERY — As noted above, surgery for radiation enteritis should be avoided if possible because of several inherent difficulties in operating on patients with chronic radiation injury
Diffuse fibrosis and adhesions between bowel loops can make resection technically challenging.
The risk of a leak is high when creating an anastomosis between irradiated tissues. Furthermore, it can be difficult to distinguish healthy tissue for irradiated tissue by gross inspection alone; intraoperative endoscopy may be helpful in this setting, but experienced is limited.
Extensive resection may be required, potentially leading to short bowel syndrome.
Despite attempts at conservative management, approximately one-third of patients progress to the point where surgery is required. Most surgical series of patients treated for radiation enteritis are small; the most common indications for surgery have been persistent ileus, intestinal fistulization, and massive adhesions. Surgical mortality rates are as high as 10 to 22 percent and many patients require more than one laparotomy
An illustrative series focused on 109 patients who underwent surgery during a 10 year period. Five patients died postoperatively (all of whom had undergone resection) while 33 (30 percent) had postoperative complications. Complications were more likely in patients who underwent emergency surgery. Repeat surgery was required in 40 percent of patients during a 40 month follow-up period. Overall survival in patients without a cancer recurrence was 85 percent at year one, and 69 percent at year five.
Strictureplasty may offer a less invasive approach to the management of strictures, but experience is limited. The role of small bowel transplantation in this setting is still being determined; its role, if any, will probably be only in children
SUMMARY AND RECOMMENDATIONS — Chronic radiation enteritis may lead to a variety of clinical consequences (such as diarrhea, nausea, weight loss, abdominal pain, intestinal obstruction and perforation) depending upon the extent of the injury. It usually develops six or more months after radiation therapy (mean approximately 5 years, range two months to as long as 30 years).
The diagnosis is usually established by suggestive radiologic findings in patients with compatible clinical features who have a history of prior radiation exposure. The patient's previous radiation treatment record should be reviewed to determine the total dose and distribution of the radiation field. This may help to determine which intestinal segments may have received excessive radiation exposure, information that can be correlated with the radiologic findings and the clinical presentation. We usually obtain an abdominal CT scan and an upper gastrointestinal series with small bowel follow-through. Further testing with an enteroclysis (standard, CT, or MRI depending upon local expertise) can be performed if the above is unrevealing and clinical suspicion remains.
Management should be conservative, addressing the predominant symptoms.
Patients with diarrhea, abdominal pain, nausea or bloating should undergo breath testing for bacterial overgrowth and treated with antibiotics if bacterial overgrowth is confirmed. Avoidance of lactose may benefit other patients while antidiarrheal agents (such as loperamide) may also be helpful. Loperamide should be avoided in patients with obstructive symptoms.
Patients with intermittent obstructive symptoms may benefit from a low residue diet, although dietary tolerance is variable. Radiologic evaluation may help to identify the strictured segment, information which may be critical should strictureplasty or surgery be ultimately required. The narrowed segment may not always be visible with an upper gastrointestinal series, particularly in patients with intermittent symptoms. Such patients may require enteroclysis as described above.
Despite conservative measures, surgery will be required in approximately 30 percent of patients. This is usually due to persistent ileus, intestinal fistulization, and massive adhesions.
Prognosis is variable since the disease is progressive. Early mortality is usually due to cancer recurrence. Five-year survival is approximately 70 percent in those without cancer recurrence, although many patients continue to have troubling digestive symptoms for the remainder of their lives.
Intensive, ongoing research on mechanisms related to fibrogenesis may eventually produce effective means to prevent or reverse disease progression once it has been established. However, at the present time, prevention during radiation therapy is central to reducing the risk of developing chronic radiation enteritis.
http://www.aboutcancer.com/radiation_enteritis_utd_807.htm
INTRODUCTION — Chronic radiation enteritis is a complication of radiation therapy for cancer, most commonly for rectal, prostate and pelvic malignancies. It can affect both the large and small intestine, is often progressive, and may lead to a variety of clinical consequences (such as diarrhea, nausea, weight loss, abdominal pain, intestinal obstruction, and perforation) depending upon the extent of the injury. It usually develops six or more months after radiation therapy (mean approximately 5 years, range two months to as long as 30 years. This contrasts with the timing of acute radiation enteritis (characterized by diarrhea and abdominal pain), which develops during or shortly after radiation therapy and resolves within two to six weeks.
The incidence has not been well defined, in part because of the large number of patients who died or were lost to follow-up in major studies involving radiation therapy, and because of the variability in the field size and dose of radiation. One literature review estimated that the incidence ranged from 1.2 to as high as 15 percent in patients with rectal cancer
This topic review will focus on the diagnosis and management of chronic radiation injury to the small intestines and proximal colon. Issues related to the prevention and treatment of chronic radiation proctitis (usually encountered following treatment of cancers of the rectum, cervix, uterus, prostate, urinary bladder, and testes) are presented separately.
PATHOGENESIS — Chronic radiation enteritis usually develops only after large doses of radiation therapy have been delivered (4500 to 5500 cGY); it is uncommon at lower doses. In addition to the dose of radiation, several other predisposing conditions have been described including:
Older age
Combined chemotherapy
Poor radiation technique
Postoperative radiation; in this setting, bowel loops fixed together by adhesions may prolapse into the pelvis, leading them to receive excessive radiation exposure. Adhesions due to past surgical procedures can have the same effect.
Intestinal injury is believed to be related to oxidative damage caused by the formation of free radicals. The end result is an obliterative endarteritis that leads to intestinal ischemia resulting in stricturing with ulceration and fibrosis and occasionally fistula formation. The physiologic consequences may include altered intestinal transit, reduced bile acid absorption, increased intestinal permeability, bacterial overgrowth and lactose malabsorption The resulting clinical manifestations may include nausea, vomiting, lactose intolerance, obstructive symptoms, diarrhea, weight loss, malnutrition, and bleeding (usually in patients with colonic involvement).
The prominent histopathologic features are those of an occlusive vasculitis with diffuse collagen deposition and fibrosis. The arteriolar walls may show a hyaline ring-like thickening and large foams cells beneath the intima. Mucosal ulceration, necrosis and perforation may develop as the disease progresses. Progressive fibrosis leads to stricturing with dilation of proximal segments. The intestinal segments and their associated serosa appear grossly thickened. Telangiectasias may be seen.
The precise mechanisms leading from oxidative damage to the histologic and morphologic abnormalities described above are incompletely understood. Several theories have been proposed, all of which are probably interrelated:
One model suggests that fibrosis develops from the initial mucosal injury
Another theory suggests that fibrosis develops in connective tissues where radiation has caused a decrease in cell turnover and a low rate of proliferation.
A third model focuses on the cellular responses to vascular damage caused by paracrine mediators. The signals leading to the developing of fibrosis are a topic of intensive ongoing investigation.
One study found that intestinal webs forming after radiation therapy demonstrated an impaired vasodilatory response in vitro to acetylcholine treatment. This microvascular dysfunction may lead to the formation of the abnormal tissue response seen in the wall of the intestine post-radiation therapy.
CLINICAL MANIFESTATIONS — The classical features of radiation enteritis are abdominal pain, nausea, vomiting, and diarrhea. Patients with severe disease may develop intermittent, partial, or complete small bowel obstruction
As noted above, bacterial overgrowth may lead to malabsorption and contribute to the nausea, abdominal pain and diarrhea. Bacterial overgrowth should be suspected in patients with intestinal strictures. Another clue may be the development of new lactose intolerance. Nonspecific symptoms include diarrhea, bloating, excessive gas, borborygmi, and nausea. Most such patients have only subtle laboratory or clinical findings pointing toward the diagnosis; thus a high index of suspicion is required. Rare patients with severe malabsorption may present with a more fulminant clinical and laboratory profile
DIAGNOSIS — The diagnosis is usually established by suggestive radiologic findings in patients with compatible clinical features who have a history of prior radiation exposure. The patient's previous radiation treatment record should be reviewed to determine the total dose and distribution of the radiation field. This may help to determine which intestinal segments may have received excessive radiation exposure, information that can be correlated with the radiologic findings and the clinical presentation.
We usually obtain an abdominal CT scan followed by an upper gastrointestinal series with small bowel follow through in patients with suspected small bowel disease. Additional imaging is reserved for patients in whom the diagnosis remains unclear. We generally perform a colonoscopy in patients with suspected colonic involvement.
Upper gastrointestinal series — An upper gastrointestinal series with small bowel follow-through is a useful initial test for evaluating the extent of disease although it is not as sensitive as enteroclysis.
Enteroclysis — Enteroclysis involves the instillation of contrast material (usually administered through a nasoenteric tube) into the small bowel using a pump (making it considerably less comfortable than a standard small bowel follow-through). It provides more detailed visualization of the small bowel compared with a standard upper gastrointestinal series. Suggestive findings include submucosal thickening, single or multiple stenoses, adhesions, and sinus or fistula formation. Its sensitivity and specificity for radiation enteritis have not been well-defined.
CT scan — Computed tomography may show thickening of bowel segments, but the findings are nonspecific. CT may be helpful in narrowing the differential diagnosis, particularly in distinguishing strictures due to radiation enteritis from those arising from abdominal metastases or a local recurrence
CT enteroclysis (in which a CT is performed after instilling contrast into the intestine using a nasoenteric tube) produces superior bowel opacification compared with conventional CT, and may therefore be useful for identifying low-grade or intermittent obstruction (reported sensitivity and specificity of approximately 88 and 82 percent, respectively). However, the technique is still used only in a few specialized centers. Similarly, other improvements in CT imaging of the small bowel (such as three-dimensional imaging) will likely also have a role in diagnosis of radiation enteritis but are not yet widely available
Magnetic resonance enteroclysis — Magnetic resonance enteroclysis permits visualization of the small bowel using similar principles as described above for CT enteroclysis. Initial studies suggest the results are comparable to (and possibly more sensitive than) CT enteroclysis. However, only small numbers of patients have been studied and the technique is not yet widely available.
Enteroscopy — Enteroscopy (peroral endoscopy of the small bowel using specialized endoscopes) has a limited role in the diagnosis of radiation enteritis although it may help to narrow the differential diagnosis. Enteroclysis can be performed following enteroscopy by leaving a tube inserted in the intestine upon withdrawal of the enteroscope.
Capsule endoscopy — There is no published experience with capsule endoscopy specifically for diagnosing radiation enteritis, although there is some clinical experience. However, it should probably not be performed in patients in whom there is a strong clinical suspicion for radiation enteritis because the capsule may become lodged in a strictured segment, requiring surgical removal.
Colonoscopy — Colonoscopy is helpful in evaluating colonic involvement and can also visualize the terminal ileum. Mucosal features consistent with radiation injury include pallor with friability and telangiectasias, which can be multiple, large, and serpiginous; these changes tend to be continuous. Although mucosal biopsies are not diagnostic, they can help to exclude other causes of proctitis such as infection or inflammatory bowel disease.
DIFFERENTIAL DIAGNOSIS — The differential diagnosis of chronic radiation enteritis is broad. Other diagnostic possibilities include post-surgical adhesions, malabsorption syndromes, abdominal metastases, lymphoma, Crohn's disease, infectious, ischemic or ulcerative colitis, and intestinal pseudo-obstruction.
MEDICAL MANAGEMENT — Prevention is the key to avoiding chronic radiation enteritis. Once established, treatment should be as conservative as possible focusing on relief of symptoms. Experience with specific medical treatments has been derived largely from small clinical trials and case series. Approaches used to treat small bowel disease will be summarized below while specific treatments aimed at radiation proctitis are discussed separately.
Dietary recommendations — There does not appear to be a clear-cut diet that reliably alleviates symptoms. A high fiber diet should probably not be recommended specifically since it may worsen diarrhea and urgency. Some patients may develop lactose intolerance, which may be due to bacterial overgrowth, and may improve following antibiotic treatment (see below). Others may require avoidance of lactose. Enteral formulas supplemented with glutamine may have a benefit but studies are limited
Antidiarrheal agents — Judicious use of antidiarrheal agents (such as loperamide) can help improve diarrhea, although it should not be used in patients with suspected small or large bowel obstruction. The efficacy of loperamide was evaluated in a crossover trial involving 18 patients with diarrhea due to radiation enteritis who were randomly assigned to loperamide or placebo for 14 days separated by a 14 day washout period. Loperamide was associated with a significant reduction in the frequency of bowel movements, slower intestinal transit, and improvement in the absorption of bile acids.
Antibiotics — Antibiotics may reduce symptoms in patients in whom bacterial overgrowth has developed. Specific testing for bacterial overgrowth is preferable to empiric therapy. A major drawback to empiric therapy is that treatment may require more than one antibiotic, and repeated and sometimes cyclic treatment. Because antibiotics may be associated with adverse effects, some of which may mimic symptoms of bacterial overgrowth (such as diarrhea and abdominal discomfort), establishing a firm diagnosis is important. This can usually be accomplished with a breath test.
5-ASA drugs — A case report (published nearly three decades ago) suggested a possible benefit from sulfasalazine with or without oral prednisone. There is no large published experience with either of these drugs. Discordant results have been obtained from controlled clinical trials evaluating mesalazine or sulfasalazine in the prevention of acute radiation enteritis
Hyperbaric oxygen — HBO has been used for treatment of refractory foot ulcers in diabetes and in other conditions [39]. The theoretical benefit of hyperbaric oxygen therapy (HBO) may be via inhibition of bacterial growth [40], preservation of marginally perfused tissue, and inhibition of toxin production [41].
A benefit in chronic radiation enteritis was suggested in a case report of a patient in whom 20 treatments over a one month period brought about objective improvements in symptoms and absorption of D-xylose. However, this anecdote did not give the results of long-term follow-up. Other reports have also suggested a benefit for patients with chronic radiation proctitis.
The equipment needed for hyperbaric oxygen treatment is expensive and not widely available. Thus, at the present time, it is not a practical means of treating chronic radiation enteritis outside of centers specializing in this approach, particularly since its effectiveness has not been well-studied.
Parenteral nutrition — A mainstay of the medical therapy of severe chronic radiation enteritis has been total parenteral nutrition (TPN), the success of which is similar for other intestinal disorders requiring TPN. One of the largest series included 54 patients who required home TPN mostly because of intestinal obstruction (27 patients), short bowel syndrome (17 patients), malabsorption (five patients), fistula formation (three patients), and dysmotility (two patients). TPN was initiated a median of 20 months after radiation therapy and was administered for a median of 20 months. Cumulative 5-year survival was 64 percent. Most early deaths were due to recurrent cancer. Similar survival estimates were reached in other series .
SURGERY — As noted above, surgery for radiation enteritis should be avoided if possible because of several inherent difficulties in operating on patients with chronic radiation injury
Diffuse fibrosis and adhesions between bowel loops can make resection technically challenging.
The risk of a leak is high when creating an anastomosis between irradiated tissues. Furthermore, it can be difficult to distinguish healthy tissue for irradiated tissue by gross inspection alone; intraoperative endoscopy may be helpful in this setting, but experienced is limited.
Extensive resection may be required, potentially leading to short bowel syndrome.
Despite attempts at conservative management, approximately one-third of patients progress to the point where surgery is required. Most surgical series of patients treated for radiation enteritis are small; the most common indications for surgery have been persistent ileus, intestinal fistulization, and massive adhesions. Surgical mortality rates are as high as 10 to 22 percent and many patients require more than one laparotomy
An illustrative series focused on 109 patients who underwent surgery during a 10 year period. Five patients died postoperatively (all of whom had undergone resection) while 33 (30 percent) had postoperative complications. Complications were more likely in patients who underwent emergency surgery. Repeat surgery was required in 40 percent of patients during a 40 month follow-up period. Overall survival in patients without a cancer recurrence was 85 percent at year one, and 69 percent at year five.
Strictureplasty may offer a less invasive approach to the management of strictures, but experience is limited. The role of small bowel transplantation in this setting is still being determined; its role, if any, will probably be only in children
SUMMARY AND RECOMMENDATIONS — Chronic radiation enteritis may lead to a variety of clinical consequences (such as diarrhea, nausea, weight loss, abdominal pain, intestinal obstruction and perforation) depending upon the extent of the injury. It usually develops six or more months after radiation therapy (mean approximately 5 years, range two months to as long as 30 years).
The diagnosis is usually established by suggestive radiologic findings in patients with compatible clinical features who have a history of prior radiation exposure. The patient's previous radiation treatment record should be reviewed to determine the total dose and distribution of the radiation field. This may help to determine which intestinal segments may have received excessive radiation exposure, information that can be correlated with the radiologic findings and the clinical presentation. We usually obtain an abdominal CT scan and an upper gastrointestinal series with small bowel follow-through. Further testing with an enteroclysis (standard, CT, or MRI depending upon local expertise) can be performed if the above is unrevealing and clinical suspicion remains.
Management should be conservative, addressing the predominant symptoms.
Patients with diarrhea, abdominal pain, nausea or bloating should undergo breath testing for bacterial overgrowth and treated with antibiotics if bacterial overgrowth is confirmed. Avoidance of lactose may benefit other patients while antidiarrheal agents (such as loperamide) may also be helpful. Loperamide should be avoided in patients with obstructive symptoms.
Patients with intermittent obstructive symptoms may benefit from a low residue diet, although dietary tolerance is variable. Radiologic evaluation may help to identify the strictured segment, information which may be critical should strictureplasty or surgery be ultimately required. The narrowed segment may not always be visible with an upper gastrointestinal series, particularly in patients with intermittent symptoms. Such patients may require enteroclysis as described above.
Despite conservative measures, surgery will be required in approximately 30 percent of patients. This is usually due to persistent ileus, intestinal fistulization, and massive adhesions.
Prognosis is variable since the disease is progressive. Early mortality is usually due to cancer recurrence. Five-year survival is approximately 70 percent in those without cancer recurrence, although many patients continue to have troubling digestive symptoms for the remainder of their lives.
Intensive, ongoing research on mechanisms related to fibrogenesis may eventually produce effective means to prevent or reverse disease progression once it has been established. However, at the present time, prevention during radiation therapy is central to reducing the risk of developing chronic radiation enteritis.
Saturday, November 05, 2011
Scientists uncover the secrets behind rapid tissue repair
10 October 2011
UK researchers have discovered how cells detect and respond to tissue damage. Their findings could open up new opportunities for improving tissue repair in patients after illness or surgery. When a tissue is wounded, cells detect damage via changes in their environment. Plasma leaking from broken blood vessels causes fibroblast cells to migrate into the damaged tissue, making the wound contract and plugging it by depositing substances such as collagen, which gives structural support to the tissue.
Now, researchers at the University of Bristol and the Wellcome Trust Centre for Cell-Matrix Research, University of Manchester - funded by the Wellcome Trust - have examined the signalling process that occurs in damaged tissues and identified the cellular mechanisms responsible for activating repair.
Lead author Dr Mark Bass said: "Each of these processes requires the turnover of cellular adhesions [repeated sticking and unsticking of cells], and the challenge has been to determine how cells detect tissue damage and modify their adhesive properties accordingly."
Using an imaging technique known as atomic force microscopy, the team were able to show how a protein, syndecan-4, triggers the uptake and redeployment of adhesive molecules. This novel sequence of signals enables fibroblasts and other cells to respond to changes in tissue structure and migrate along the matrix fibres which make up the skin. By moving towards a damage signal, cells are able to arrive at the wound far more quickly than if they searched for it randomly. This results in a very efficient healing response.
Dr Bass added: "We find that this signalling cascade is essential for efficient healing; this opens up considerable opportunities for improving tissue repair in patients."
Image: A scanning electron micrograph of the underside of a sticking plaster used to treat a razor blade cut. Credit: Anne Weston, LRI, CRUK, Wellcome Images.
Reference
Bass MD et al. A syndecan-4 hair trigger initiates wound healing through caveolin- and RhoG-regulated integrin endocytosis. Developmental Cell 2011 (epub ahead of print).
http://www.wellcome.ac.uk/News/2011/News/WTVM053022.htm
UK researchers have discovered how cells detect and respond to tissue damage. Their findings could open up new opportunities for improving tissue repair in patients after illness or surgery. When a tissue is wounded, cells detect damage via changes in their environment. Plasma leaking from broken blood vessels causes fibroblast cells to migrate into the damaged tissue, making the wound contract and plugging it by depositing substances such as collagen, which gives structural support to the tissue.
Now, researchers at the University of Bristol and the Wellcome Trust Centre for Cell-Matrix Research, University of Manchester - funded by the Wellcome Trust - have examined the signalling process that occurs in damaged tissues and identified the cellular mechanisms responsible for activating repair.
Lead author Dr Mark Bass said: "Each of these processes requires the turnover of cellular adhesions [repeated sticking and unsticking of cells], and the challenge has been to determine how cells detect tissue damage and modify their adhesive properties accordingly."
Using an imaging technique known as atomic force microscopy, the team were able to show how a protein, syndecan-4, triggers the uptake and redeployment of adhesive molecules. This novel sequence of signals enables fibroblasts and other cells to respond to changes in tissue structure and migrate along the matrix fibres which make up the skin. By moving towards a damage signal, cells are able to arrive at the wound far more quickly than if they searched for it randomly. This results in a very efficient healing response.
Dr Bass added: "We find that this signalling cascade is essential for efficient healing; this opens up considerable opportunities for improving tissue repair in patients."
Image: A scanning electron micrograph of the underside of a sticking plaster used to treat a razor blade cut. Credit: Anne Weston, LRI, CRUK, Wellcome Images.
Reference
Bass MD et al. A syndecan-4 hair trigger initiates wound healing through caveolin- and RhoG-regulated integrin endocytosis. Developmental Cell 2011 (epub ahead of print).
http://www.wellcome.ac.uk/News/2011/News/WTVM053022.htm
Friday, November 04, 2011
MAUDE Adverse Event Report ~ Abdolift and Spray Gel
FDA Home> Medical Devices> DatabasesMAUDE Adverse Event Report
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
CONFLUCENT SPRAYGEL ADHESION BARRIER SYSTEM Back to Search Results
Model Number PK-A-6010
Event Date 02/07/2003
Event Type Injury Patient Outcome Required Intervention;
Event Description
The pt reported that she had problems with adhesions and pain. She had surgery performed at endogyn in another country, to remove the adhesions. The procedure was performed using a gasless laparoscopy technique with an abdominal wall retractor. The adhesions returned within 2 months of the surgery and after 6 months the adhesions became calcified. The pt claims that the surgery has damaged her internalorgans. She believes that the method of using the abdominal wall retractor with gasless laparoscopy is detrimental to the pt. She subsequently had additional surgery performed in the united states because of problems related to the surgery in another country.
Manufacturer Narrative
Confluent surgical was named as the mfr in medwatch report. The device named in the report is "abdominal wall retractor" Abdolift. Confluent surgical does not mfr, market, or distribute this device. When contacted by confluent, the reporter stated that the confluent product used in the surgery is spraygel. The "abdominal wall retractor", which is mfg by another co, was also used in the surgery. The event did not occur in the united states, it occurred in another country. Spraygel is not marketed or distributed in the united states. The reporter's complaint concerned the method of gasless laparoscopy and the use of the abdominal wall retractor, not the use of spraygel.
Search Alerts/Recalls
New Search | Submit an Adverse Event Report
Brand Name SPRAYGEL ADHESION BARRIER SYSTEM
Manufacturer (Section F) CONFLUCENT
boston MA *
Manufacturer (Section D) CONFLUENT SURGICAL INC.
waltham MA *
Manufacturer Contact amita shah
101a first ave
waltham , MA 02451
(781) 839 -1726
Device Event Key 830606
MDR Report Key 878848
Event Key 806304
Report Number 3003157248-2007-00001
Device Sequence Number 1
Product Code MCN
Report Source Manufacturer
Source Type Other
Reporter Occupation Patient
Type of Report Initial
Report Date 05/14/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 06/25/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number PK-A-6010
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received 05/14/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Unkown
Patient TREATMENT DATA
Date Received: 06/25/2007 Patient Sequence Number: 1
# Treatment Treatment Date
ABDOMINAL WALL RETRACTOR USED IN GASLESS
2,LAPAROSCOPY
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=878848
---Page Last Updated: 10/31/2011
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
CONFLUCENT SPRAYGEL ADHESION BARRIER SYSTEM Back to Search Results
Model Number PK-A-6010
Event Date 02/07/2003
Event Type Injury Patient Outcome Required Intervention;
Event Description
The pt reported that she had problems with adhesions and pain. She had surgery performed at endogyn in another country, to remove the adhesions. The procedure was performed using a gasless laparoscopy technique with an abdominal wall retractor. The adhesions returned within 2 months of the surgery and after 6 months the adhesions became calcified. The pt claims that the surgery has damaged her internalorgans. She believes that the method of using the abdominal wall retractor with gasless laparoscopy is detrimental to the pt. She subsequently had additional surgery performed in the united states because of problems related to the surgery in another country.
Manufacturer Narrative
Confluent surgical was named as the mfr in medwatch report. The device named in the report is "abdominal wall retractor" Abdolift. Confluent surgical does not mfr, market, or distribute this device. When contacted by confluent, the reporter stated that the confluent product used in the surgery is spraygel. The "abdominal wall retractor", which is mfg by another co, was also used in the surgery. The event did not occur in the united states, it occurred in another country. Spraygel is not marketed or distributed in the united states. The reporter's complaint concerned the method of gasless laparoscopy and the use of the abdominal wall retractor, not the use of spraygel.
Search Alerts/Recalls
New Search | Submit an Adverse Event Report
Brand Name SPRAYGEL ADHESION BARRIER SYSTEM
Manufacturer (Section F) CONFLUCENT
boston MA *
Manufacturer (Section D) CONFLUENT SURGICAL INC.
waltham MA *
Manufacturer Contact amita shah
101a first ave
waltham , MA 02451
(781) 839 -1726
Device Event Key 830606
MDR Report Key 878848
Event Key 806304
Report Number 3003157248-2007-00001
Device Sequence Number 1
Product Code MCN
Report Source Manufacturer
Source Type Other
Reporter Occupation Patient
Type of Report Initial
Report Date 05/14/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 06/25/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number PK-A-6010
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received 05/14/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Unkown
Patient TREATMENT DATA
Date Received: 06/25/2007 Patient Sequence Number: 1
# Treatment Treatment Date
ABDOMINAL WALL RETRACTOR USED IN GASLESS
2,LAPAROSCOPY
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=878848
---Page Last Updated: 10/31/2011
Current Trials from Clinicaltrials.gov ~ Keyword Adhesiolysis
Current Trials from Clinicaltrials.gov ~ Keyword Adhesiolysis
http://www.clinicaltrials.gov/ct2/results?term=adhesiolysis
Found 13 studies with search of: adhesiolysis
Hide studies that are not seeking new volunteers.
Hide studies with unknown recruitment status. Display Options Rank Status Study
1 Active, not recruiting The Effect of Adhesiolysis During Elective Abdominal Surgery on Per- and Postoperative Complication, Quality of Life and Socioeconomic Costs Condition: Tissue Adhesions
Intervention: Procedure: Adhesiolysis
2 Enrolling by invitation A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections Condition: Low Back Pain
Interventions: Procedure: Caudal Epidural Injection; Procedure: percutaneous adhesiolysis
3 Active, not recruiting Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain Condition: Chronic Low Back Pain
Interventions: Procedure: Percutaneous adhesiolysis with hypertonic saline neurolysis; Device: RK needle and Racz catheter system; Drug: local anesthetic, steroid, 10% sodium chloride solution
4 Enrolling by invitation Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients Condition: Low Back Pain
Interventions: Drug: Celestone; Drug: Substitute Celestone; Drug: Substitute Hypertonic Sodium Chloride; Drug: Substitute hypertonic sodium chloride and Celestone
5 Not yet recruiting Adhesiolysis in Chronic Abdominal Pain Condition: Chronic Abdominal Pain
Interventions: Procedure: Laparoscopic adhesiolysis; Procedure: Placebo-surgery
6 Recruiting Comparative Effectiveness Multicenter Trial for Adhesion Characteristics of Ventral Hernia Repair Mesh Conditions: Ventral Hernia; Adhesions
Intervention: Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery
7 Not yet recruiting Prospective Multicenter Validation of a Severity Score of Strangulated Small Bowel Occlusion Condition: Intestinal Obstruction
Intervention: Procedure: Conservative treatment versus surgical treatment
8 Not yet recruiting An Adhesion Reduction Plan in the Management of the Surgical Open Abdomen Condition: Open Abdomen
Intervention: Procedure: Adhesion Reduction Plan
9 Recruiting Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions. Conditions: Safety of Intervention; Efficacy of Intervention; Cost Effectiveness
Interventions: Procedure: VATS hyperthermic chemoperfusion; Procedure: Bedside talc slurry pleurodesis
10 Completed Study of Fluid Collection of the Chest in Children With Pneumonia Conditions: Community Acquired Bacterial Pneumonia; Paraneumonic Effusion
Intervention: Procedure: Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage
11 Unknown † Seprafilm® for Prevention of Adhesions at Repeat Cesarean Condition: Adhesion Formation After Primary Cesarean Delivery
Interventions: Device: Seprafilm®; Other: Control
12 Unknown † Functional Outcome After Incisional Hernia Repair: Open Versus Laparoscopic Repair Conditions: Hernia, Ventral; Body Image; Respiratory Function Tests; Quality of Life; Laparoscopy
Interventions: Procedure: Laparoscopic repair; Procedure: Open midline incisional hernia repair
13 Recruiting Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor Conditions: Advanced Cancers; Sarcoma
Interventions: Procedure: Hyperthermic Peritoneal Perfusion (HIPEC); Drug: Cisplatin
http://www.clinicaltrials.gov/ct2/results?term=adhesiolysis
Found 13 studies with search of: adhesiolysis
Hide studies that are not seeking new volunteers.
Hide studies with unknown recruitment status. Display Options Rank Status Study
1 Active, not recruiting The Effect of Adhesiolysis During Elective Abdominal Surgery on Per- and Postoperative Complication, Quality of Life and Socioeconomic Costs Condition: Tissue Adhesions
Intervention: Procedure: Adhesiolysis
2 Enrolling by invitation A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections Condition: Low Back Pain
Interventions: Procedure: Caudal Epidural Injection; Procedure: percutaneous adhesiolysis
3 Active, not recruiting Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain Condition: Chronic Low Back Pain
Interventions: Procedure: Percutaneous adhesiolysis with hypertonic saline neurolysis; Device: RK needle and Racz catheter system; Drug: local anesthetic, steroid, 10% sodium chloride solution
4 Enrolling by invitation Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients Condition: Low Back Pain
Interventions: Drug: Celestone; Drug: Substitute Celestone; Drug: Substitute Hypertonic Sodium Chloride; Drug: Substitute hypertonic sodium chloride and Celestone
5 Not yet recruiting Adhesiolysis in Chronic Abdominal Pain Condition: Chronic Abdominal Pain
Interventions: Procedure: Laparoscopic adhesiolysis; Procedure: Placebo-surgery
6 Recruiting Comparative Effectiveness Multicenter Trial for Adhesion Characteristics of Ventral Hernia Repair Mesh Conditions: Ventral Hernia; Adhesions
Intervention: Procedure: Clinically-Indicated Abdominal Re-Exploration Surgery
7 Not yet recruiting Prospective Multicenter Validation of a Severity Score of Strangulated Small Bowel Occlusion Condition: Intestinal Obstruction
Intervention: Procedure: Conservative treatment versus surgical treatment
8 Not yet recruiting An Adhesion Reduction Plan in the Management of the Surgical Open Abdomen Condition: Open Abdomen
Intervention: Procedure: Adhesion Reduction Plan
9 Recruiting Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions. Conditions: Safety of Intervention; Efficacy of Intervention; Cost Effectiveness
Interventions: Procedure: VATS hyperthermic chemoperfusion; Procedure: Bedside talc slurry pleurodesis
10 Completed Study of Fluid Collection of the Chest in Children With Pneumonia Conditions: Community Acquired Bacterial Pneumonia; Paraneumonic Effusion
Intervention: Procedure: Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage
11 Unknown † Seprafilm® for Prevention of Adhesions at Repeat Cesarean Condition: Adhesion Formation After Primary Cesarean Delivery
Interventions: Device: Seprafilm®; Other: Control
12 Unknown † Functional Outcome After Incisional Hernia Repair: Open Versus Laparoscopic Repair Conditions: Hernia, Ventral; Body Image; Respiratory Function Tests; Quality of Life; Laparoscopy
Interventions: Procedure: Laparoscopic repair; Procedure: Open midline incisional hernia repair
13 Recruiting Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor Conditions: Advanced Cancers; Sarcoma
Interventions: Procedure: Hyperthermic Peritoneal Perfusion (HIPEC); Drug: Cisplatin
Innocoll Announces European Approval for CollaGUARD®, Surgical Adhesion Barrier
ASHBURN, Va., Oct. 11, 2011 /PRNewswire/ -- Innocoll, Inc. announces the approval of CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic surgery. The product will be launched this year through a network of distribution partnerships. The company also plans to seek approval in a number of additional territories, including Australia, Canada, the MENA region, South East Asia, and to initiate the studies required for registration in the US.
Dr. Michael Myers, President and CEO commented, "EU registration for CollaGUARD represents an important milestone for Innocoll. This is the first significant approval for a product developed using our proprietary CollaFilm™ technology and we are on track to launch this year. With Cogenzia® ready to start Phase 3 testing and following the recent announcement of positive XaraColl® Phase 2 clinical data coupled with US/EU approval of a broad range of advanced woundcare products, Innocoll is assembling an exciting portfolio of late stage assets. We look forward to further positive developments for our products and technologies throughout 2012 and beyond."
About CollaGUARD®
CollaGUARD is a transparent bioresorbable film of 100% type I collagen that has been developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. CollaGUARD is implanted at the time of surgery and serves as a temporary barrier to separate apposing adhesiogenic surfaces throughout the normal tissue repair process. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P < 0.001) and significantly reduced the extent and severity of adhesions (P < 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
About Postoperative Adhesions
Postoperative adhesions are abnormal fibrous connections that can form between any apposing internal organ and serous membrane as a natural consequence of abdominopelvic surgery. Adhesions occur in almost 95% of laparotomies and may lead to serious complications such as intestinal obstruction, secondary female infertility, and chronic abdominal or pelvic pain. More than 30% of patients who undergo open gynecologic or general surgery are readmitted within 10 years for disorders that are considered directly or potentially related to adhesions, with an average of 2 readmissions per patient. In the United States, there are approximately 350,000 hospitalizations annually for adhesiolysis following gynecologic or abdominal surgery, which account for almost 1 million inpatient days at a cost of $2.3 billion. Even for patients without complications, adhesions originating from a previous surgery can present significant surgical challenges and additional morbidity risks in subsequent operations.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx®, CollaFilm, DermaSil™, CollaPressTM and Liquicoll®. Approved products based on the Company's technologies include: Collatamp® G, Septocoll®, CollaGUARD, Collieva®, CollaCare®, Collexa®, Zorpreva™, and LidoColl®.
Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com.
SOURCE Innocoll, Inc.
Back to top
RELATED LINKS
http://www.innocollinc.com/
http://www.prnewswire.com/news-releases/innocoll-announces-european-approval-for-collaguard-surgical-adhesion-barrier-131504353.html
Dr. Michael Myers, President and CEO commented, "EU registration for CollaGUARD represents an important milestone for Innocoll. This is the first significant approval for a product developed using our proprietary CollaFilm™ technology and we are on track to launch this year. With Cogenzia® ready to start Phase 3 testing and following the recent announcement of positive XaraColl® Phase 2 clinical data coupled with US/EU approval of a broad range of advanced woundcare products, Innocoll is assembling an exciting portfolio of late stage assets. We look forward to further positive developments for our products and technologies throughout 2012 and beyond."
About CollaGUARD®
CollaGUARD is a transparent bioresorbable film of 100% type I collagen that has been developed using Innocoll's proprietary CollaFilm technology. It is approved in Europe for the prevention of postoperative adhesions in patients undergoing abdominopelvic laparotomy or laparoscopy. CollaGUARD is implanted at the time of surgery and serves as a temporary barrier to separate apposing adhesiogenic surfaces throughout the normal tissue repair process. When tested in vivo, CollaGUARD increased the probability of remaining adhesion-free by more than six fold (P < 0.001) and significantly reduced the extent and severity of adhesions (P < 0.001).
CollaGUARD has been designed and engineered with a unique combination of features for optimal handling, ease-of-use, and antiadhesion performance. It is highly stable at room temperature and does not require any advanced preparation before use. The product is non-tacky and can be easily rolled for insertion through a trocar when implanted laparoscopically. CollaGUARD is available in a wide variety of sizes up to 20 x 30 cm; it may be cut and sutured if required and therefore used efficiently across a broad range of surgeries.
About Postoperative Adhesions
Postoperative adhesions are abnormal fibrous connections that can form between any apposing internal organ and serous membrane as a natural consequence of abdominopelvic surgery. Adhesions occur in almost 95% of laparotomies and may lead to serious complications such as intestinal obstruction, secondary female infertility, and chronic abdominal or pelvic pain. More than 30% of patients who undergo open gynecologic or general surgery are readmitted within 10 years for disorders that are considered directly or potentially related to adhesions, with an average of 2 readmissions per patient. In the United States, there are approximately 350,000 hospitalizations annually for adhesiolysis following gynecologic or abdominal surgery, which account for almost 1 million inpatient days at a cost of $2.3 billion. Even for patients without complications, adhesions originating from a previous surgery can present significant surgical challenges and additional morbidity risks in subsequent operations.
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx®, CollaFilm, DermaSil™, CollaPressTM and Liquicoll®. Approved products based on the Company's technologies include: Collatamp® G, Septocoll®, CollaGUARD, Collieva®, CollaCare®, Collexa®, Zorpreva™, and LidoColl®.
Other products in clinical and regulatory development include: CollaRx Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections, Cogenzia in phase 3 for the adjuvant treatment of infected diabetic foot ulcers, and Xaracoll in phase 2b for the management of post-operative pain. For more information, please visit www.innocollinc.com.
SOURCE Innocoll, Inc.
Back to top
RELATED LINKS
http://www.innocollinc.com/
http://www.prnewswire.com/news-releases/innocoll-announces-european-approval-for-collaguard-surgical-adhesion-barrier-131504353.html
Thursday, November 03, 2011
Dolphin-Assisted Therapy: Something Magical in the Water
Excerpt from Huffington Post
In an ongoing pilot study -- Researching the Effects of Dolphin Assisted Therapy at CDTC on Brain Activity -- in cooperation with the German Society of Air and Space Medicine and Research, DolphinAid and the Neurological Clinic Vogtareuth, scientists used water-proof EEG equipment to measure how human brain waves change in interactions with dolphins. The preliminary results have been called "promising." Other research, including an accredited project on children, dolphins and depression, is noted below.(1)
One hypothesis suggests that our brain waves sync to be in resonance with the frequencies of those of dolphins when we're exposed to them. Our normal activity in everyday thought is in beta wavelength. Upon exposure to dolphins, our brainwaves have been measured to go into alpha (the relaxation, effortless alertness, peak performances, daydreaming state, producing lower anxiety and better immune system function) and theta (the meditative state). Moreover, an increase by significant measure of hemispheric synchronization (the balancing of right and left hemispheres in the brain, which is associated with heightened awareness and increased ability to learn) was registered. (2)
Since our normal activity in everyday thought is in beta, we go into alpha during the "ah-ha" phenomenon when we have a great idea while driving or showering. You've doubtless had that wonderful experience. It's a gestalt, out of time, not a linear thought to be explained in one word after another, even as you read these consecutive words here. Rather it is grasped as a whole and then later translated into its discrete units. Einstein explained it to a friend this way: "Thoughts did not come in any verbal formation. I rarely think in words at all. A thought comes, and I try to express it in words afterward." That time-free knowing is exhilarating for certain. And this may partly explain the feeling.
Then there's the sonar.
Dolphins use their sonar/ultrasound to scan the world around them. Medical science uses ultrasound in pregnancies and for diagnostic information, to promote healing and to destroy cataracts, kidney stones and gallstones. Sounds in general can influence our biology, such as our heart rate. Ultrasonic energy from dolphins, is four times stronger than that applied medically. The medium through which it is transmitted, water, has an efficiency of delivering sound that is 60 times more efficient than air.
Because our bodies are primarily made of water, including the fluid that moves from the brain to the spinal cord, this interaction may be extremely defining. It may even help to reduce adhesions and scarring from old surgeries. (3) (4) They read the world around them, almost like an X-ray, with this capacity which even the Navy has discovered very useful. This is likely how Mateo knew about the boy's surgery. (5)
Click here to read entire article: http://www.huffingtonpost.com/judith-simon-prager-phd/dolphin-assisted-therapy_b_996389.html
In an ongoing pilot study -- Researching the Effects of Dolphin Assisted Therapy at CDTC on Brain Activity -- in cooperation with the German Society of Air and Space Medicine and Research, DolphinAid and the Neurological Clinic Vogtareuth, scientists used water-proof EEG equipment to measure how human brain waves change in interactions with dolphins. The preliminary results have been called "promising." Other research, including an accredited project on children, dolphins and depression, is noted below.(1)
One hypothesis suggests that our brain waves sync to be in resonance with the frequencies of those of dolphins when we're exposed to them. Our normal activity in everyday thought is in beta wavelength. Upon exposure to dolphins, our brainwaves have been measured to go into alpha (the relaxation, effortless alertness, peak performances, daydreaming state, producing lower anxiety and better immune system function) and theta (the meditative state). Moreover, an increase by significant measure of hemispheric synchronization (the balancing of right and left hemispheres in the brain, which is associated with heightened awareness and increased ability to learn) was registered. (2)
Since our normal activity in everyday thought is in beta, we go into alpha during the "ah-ha" phenomenon when we have a great idea while driving or showering. You've doubtless had that wonderful experience. It's a gestalt, out of time, not a linear thought to be explained in one word after another, even as you read these consecutive words here. Rather it is grasped as a whole and then later translated into its discrete units. Einstein explained it to a friend this way: "Thoughts did not come in any verbal formation. I rarely think in words at all. A thought comes, and I try to express it in words afterward." That time-free knowing is exhilarating for certain. And this may partly explain the feeling.
Then there's the sonar.
Dolphins use their sonar/ultrasound to scan the world around them. Medical science uses ultrasound in pregnancies and for diagnostic information, to promote healing and to destroy cataracts, kidney stones and gallstones. Sounds in general can influence our biology, such as our heart rate. Ultrasonic energy from dolphins, is four times stronger than that applied medically. The medium through which it is transmitted, water, has an efficiency of delivering sound that is 60 times more efficient than air.
Because our bodies are primarily made of water, including the fluid that moves from the brain to the spinal cord, this interaction may be extremely defining. It may even help to reduce adhesions and scarring from old surgeries. (3) (4) They read the world around them, almost like an X-ray, with this capacity which even the Navy has discovered very useful. This is likely how Mateo knew about the boy's surgery. (5)
Click here to read entire article: http://www.huffingtonpost.com/judith-simon-prager-phd/dolphin-assisted-therapy_b_996389.html
Wednesday, November 02, 2011
Deaths from painkiller overdose triple in decade
By STEPHANIE NANO - Associated Press
AP – 13 hrs ago..
NEW YORK (AP) — The number of overdose deaths from powerful painkillers more than tripled over a decade, the government reported Tuesday — a trend that a U.S. health official called an epidemic, but one that can be stopped.
Prescription painkillers such as OxyContin, Vicodin and methadone led to the deaths of almost 15,000 people in 2008, including actor Heath Ledger. That's more than three times the 4,000 deaths from narcotics in 1999.
Such painkillers "are meant to help people who have severe pain," said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention in Atlanta, which issued the report. "They are, however, highly addictive."
The report shows nearly 5 percent of Americans ages 12 and older said they've abused painkillers in the past year — using them without a prescription or just for the high. In 2008-09 surveys, Oklahomans reported the highest rate of abuse; the lowest was in Nebraska and Iowa.
The overdose deaths reflect the spike in the number of narcotic painkillers prescribed every year — enough to give every American a one-month supply, Frieden said.
Prescriptions rose as doctors aimed to better treat pain and as new painkillers hit the market.
Frieden and White House drug czar Gil Kerlikowske, who joined him at CDC headquarters in Atlanta, said states need to take sharp actions to reverse the long-running trend.
States oversee prescription practices and can rigorously monitor prescriptions and crack down on "pill mills" and "doctor shopping" by patients, Frieden said.
Click here to read the rest: http://news.yahoo.com/deaths-painkiller-overdose-triple-decade-160401910.html
AP – 13 hrs ago..
NEW YORK (AP) — The number of overdose deaths from powerful painkillers more than tripled over a decade, the government reported Tuesday — a trend that a U.S. health official called an epidemic, but one that can be stopped.
Prescription painkillers such as OxyContin, Vicodin and methadone led to the deaths of almost 15,000 people in 2008, including actor Heath Ledger. That's more than three times the 4,000 deaths from narcotics in 1999.
Such painkillers "are meant to help people who have severe pain," said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention in Atlanta, which issued the report. "They are, however, highly addictive."
The report shows nearly 5 percent of Americans ages 12 and older said they've abused painkillers in the past year — using them without a prescription or just for the high. In 2008-09 surveys, Oklahomans reported the highest rate of abuse; the lowest was in Nebraska and Iowa.
The overdose deaths reflect the spike in the number of narcotic painkillers prescribed every year — enough to give every American a one-month supply, Frieden said.
Prescriptions rose as doctors aimed to better treat pain and as new painkillers hit the market.
Frieden and White House drug czar Gil Kerlikowske, who joined him at CDC headquarters in Atlanta, said states need to take sharp actions to reverse the long-running trend.
States oversee prescription practices and can rigorously monitor prescriptions and crack down on "pill mills" and "doctor shopping" by patients, Frieden said.
Click here to read the rest: http://news.yahoo.com/deaths-painkiller-overdose-triple-decade-160401910.html
Tuesday, November 01, 2011
Companies pitch ideas to angel investors at MedVentures
Bill Hethcock
Staff Writer - Dallas Business Journal
Email Dallas Business Journal by Bill Hethcock, Staff Writer
Date: Thursday, October 6, 2011, 3:00pm CDT - Last Modified: Thursday, October 6, 2011, 3:02pm CDT
I spent the morning at the MedVentures conference in Frisco, hosted by the North Texas Enterprise Center.
The conference is where companies with ideas and plans for medical instruments and devices, diagnostic equipment and other health-related products make their pitch for advice and, more importantly, money from venture capital and angel investors to get their businesses off the ground.
Interesting products in development by some of the presenting companies include:
• Coltrix Biomedical, a Fort Worth-based preclinical-stage company whose mission is to deliver collagen-based medical devices that improve surgical outcomes, has a product called Collapatch. It's a membrane that prevents the formation of adhesions, an internal form of scarring, after surgery. These adhesions result in 300,000 readmissions annually to U.S. hospitals at a cost of $1.3 billion.
• Plano-based Neuro Resource Group .Neuro Resource Group Latest from The Business Journals Emerging Tech Fund faces possible cutsDataInfoCom granted .6M from ETFDataInfoCom granted .6M from ETF Follow this company .'s InterX is a non-invasive solution for acute and chronic pain. Clinical trials have demonstrated InterX significantly reduces pain and decreases the intake of opioids and other pain medication.
• Arcos Inc., based in Houston, has developed decision-support software to battle sepsis, a severe illness in which the bloodstream is overwhelmed by bacteria. In one test, the "Sepsis Toolkit" enabled one hospital to lower its severe sepsis mortality from 34 percent to 14 percent.
Bill covers health care, law, education and nonprofits.
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.Related:Banking & Financial Services, Health Care, Technology, Frisco
http://www.bizjournals.com/dallas/blog/2011/10/companies-pitch-ideas-to-angel.html
..
Staff Writer - Dallas Business Journal
Email Dallas Business Journal by Bill Hethcock, Staff Writer
Date: Thursday, October 6, 2011, 3:00pm CDT - Last Modified: Thursday, October 6, 2011, 3:02pm CDT
I spent the morning at the MedVentures conference in Frisco, hosted by the North Texas Enterprise Center.
The conference is where companies with ideas and plans for medical instruments and devices, diagnostic equipment and other health-related products make their pitch for advice and, more importantly, money from venture capital and angel investors to get their businesses off the ground.
Interesting products in development by some of the presenting companies include:
• Coltrix Biomedical, a Fort Worth-based preclinical-stage company whose mission is to deliver collagen-based medical devices that improve surgical outcomes, has a product called Collapatch. It's a membrane that prevents the formation of adhesions, an internal form of scarring, after surgery. These adhesions result in 300,000 readmissions annually to U.S. hospitals at a cost of $1.3 billion.
• Plano-based Neuro Resource Group .Neuro Resource Group Latest from The Business Journals Emerging Tech Fund faces possible cutsDataInfoCom granted .6M from ETFDataInfoCom granted .6M from ETF Follow this company .'s InterX is a non-invasive solution for acute and chronic pain. Clinical trials have demonstrated InterX significantly reduces pain and decreases the intake of opioids and other pain medication.
• Arcos Inc., based in Houston, has developed decision-support software to battle sepsis, a severe illness in which the bloodstream is overwhelmed by bacteria. In one test, the "Sepsis Toolkit" enabled one hospital to lower its severe sepsis mortality from 34 percent to 14 percent.
Bill covers health care, law, education and nonprofits.
See all your followed company news on your personalized dashboard.
To access the full benefits of bizWatch and receive a weekly email with aggregated news on all the companies you are following, please provide your email address below.
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.Related:Banking & Financial Services, Health Care, Technology, Frisco
http://www.bizjournals.com/dallas/blog/2011/10/companies-pitch-ideas-to-angel.html
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