Status:
COMPLETED
Large Abdominal Hernia Repair With SurgiMend 3.0
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Massachusetts General Hospital
Boston Medical Center
Conditions:
Hernia
Eligibility:
All Genders
19+ years
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00892333
Start Date
April 1 2009
End Date
July 1 2014
Last Update
May 17 2016
Active Locations (8)
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1
Los Angeles County/University of Southern California Medical Center
Los Angeles, California, United States, 90033
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
3
Cook County Hospital
Chicago, Illinois, United States, 60612
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114