Clinical Trial: Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prospective, Multicenter, Observational Study Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biosynthetic Material for Midline Fascial Closur

Brief Summary: Prospective, multicenter, observational study to evaluate performance of GORE® BIO-A® Tissue Reinforcement when used to reinforce midline fascial closure in single-staged open complex ventral incisional hernia repair.

Detailed Summary: The study will evaluate the performance of the biosynthetic mesh when used to reinforce the midline fascial closure in single-staged open complex ventral incisional hernia repair. It is designed to test the null hypothesis that the two year recurrence rate associated with the device is greater than or equal to 50% vs the alternative hypothesis that the two year recurrence rate is less than 50%.
Sponsor: W.L.Gore & Associates

Current Primary Outcome: Hernia Recurrence Rate [ Time Frame: at about 24 months ]

Investigator confirmed hernia recurrence by physical examination


Original Primary Outcome: Hernia Recurrence Rate [ Time Frame: at about 24 months ]

Current Secondary Outcome: Early and Long-term Complication Rates [ Time Frame: after surgery (day 1) to 24 months ]

Surgical site abdominal wound event rate


Original Secondary Outcome: Early and Long-term Complication Rates [ Time Frame: after surgery (day 1) to 24 months ]

Information By: W.L.Gore & Associates

Dates:
Date Received: March 28, 2011
Date Started: February 2011
Date Completion:
Last Updated: November 18, 2015
Last Verified: November 2015