Large Abdominal Hernia Repair With SurgiMend 3.0
- Conditions
- Hernia
- Registration Number
- NCT00892333
- Lead Sponsor
- Integra LifeSciences Corporation
- Brief Summary
The rate of hernia recurrence at one year following repair of a large abdominal hernia with a biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of 40%. The purpose of this study is to evaluate the rate of hernia recurrence at one year following repair with SurgiMend 3.0, an FDA-cleared novel biologic mesh, the hypothesis being that such rate will be less than 20% at one year, representing a 50% reduction over the historic rate of 40%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
All three of the following criteria must be present for enrollment into the study:
- Large abdominal hernia
- Inability to close the fascia primarily
- Contra-indication for the use of synthetic mesh
- Age > 18 years
- Use of SurgiMend 3.0 to simply reinforce a complete closure of the fascia performed either primarily or sequentially or by component separation technique
- Inability to close the skin over the SurgiMend 3.0
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hernia recurrence 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Los Angeles County/University of Southern California Medical Center
🇺🇸Los Angeles, California, United States
Cook County Hospital
🇺🇸Chicago, Illinois, United States
State University of New York (SUNY), Upstate Medical Center
🇺🇸Syracuse, New York, United States
Oregon Health and Science University (OHSU)
🇺🇸Portland, Oregon, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Oklahoma University
🇺🇸Oklahoma City, Oklahoma, United States