Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT02587403
Brief Summary:
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 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.
Study:
NCT02587403
Study Brief:
Protocol Section:
NCT02587403