Last updated on September 2018

A Comparison of Fortiva and Strattice Tissue Matrices in Complex Ventral Hernia Repair

Brief description of study

The objective of this study is to compare the effectiveness of Fortiva Porcine Dermis versus Strattice Reconstructive Tissue Matrix for the underlay reinforcement of complex ventral hernia repair and assess post-operative complication rates, long term hernia recurrence rates.

Detailed Study Description

This is a randomized, prospective, double-blinded study evaluating the efficacy of Fortiva Porcine Dermis versus Strattice Reconstructive Tissue Matrix in 120 patients with large complex abdominal wall ventral hernias undergoing single stage repair. The patient will be blinded to treatment as well as an independent qualified evaluator to confirm evidence of reoccurrence. This post-market study compares two FDA cleared biologic hernia materials. Fortiva porcine dermis, processed by RTI Surgical, Inc., a non-cross linked porcine dermis will be compared to Strattice Reconstructive Tissue Matrix by Life Cell, a non-cross linked porcine dermis for reinforcement during the single stage open reconstruction of abdominal wall defects. The primary outcome will be hernia recurrence at 1 year. Outcomes will be evaluated at 6 weeks, 3 months, 6 months and 12 months and 24 months.

Clinical Study Identifier: NCT02587403

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Grant Bochicchio, MD

Washington University
Saint Louis, MO United States
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Recruitment Status: Open

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