Clinical Trial: Large Abdominal Hernia Repair With SurgiMend 3.0
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Repair of Large Abdominal Hernia Defects By A Novel Biologic Mesh: A Prospective Multi-Center Observational Study
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 Summary:
Sponsor: Integra LifeSciences Corporation
Current Primary Outcome: Hernia recurrence [ Time Frame: 1 year ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Integra LifeSciences Corporation
Dates:
Date Received: April 29, 2009
Date Started: April 2009
Date Completion:
Last Updated: May 16, 2016
Last Verified: May 2016