NCT02587403

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

A Randomized, Prospective Study Comparing Fortiva™ Porcine Dermis vs. Strattice™ Reconstructive Tissue Matrix in Patients Undergoing Complex Open Primary Ventral Hernia Repair

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: RTI Surgical · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
DEVICE	Fortiva™ Porcine Dermis	Fortiva Porcine Dermis implantation during repair of complex ventral hernia
DEVICE	Strattice™ Reconstructive Tissue Matrix	Strattice tissue matrix implanted during repair of complex ventral hernia

Timeline

• Start date: 2015-12-02
• Primary completion: 2023-09-19
• Completion: 2023-09-19
• First posted: 2015-10-27
• Last updated: 2024-12-27
• Results posted: 2024-12-27

Locations

1 site across 1 country: United States