Trials / Completed
CompletedNCT00892333
Large Abdominal Hernia Repair With SurgiMend 3.0
Repair of Large Abdominal Hernia Defects By A Novel Biologic Mesh: A Prospective Multi-Center Observational Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 122 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Accepted
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%.
Conditions
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2014-07-01
- Completion
- 2014-07-01
- First posted
- 2009-05-04
- Last updated
- 2016-05-17
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00892333. Inclusion in this directory is not an endorsement.