Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 5:19 PM
Study NCT ID:
NCT02587403
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2015-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of Fortiva and Strattice Tissue Matrices in Complex, Ventral Hernia Repair
Sponsor:
RTI Surgical
Organization:
Study Overview
Official Title:
A Randomized, Prospective Study Comparing Fortiva™ Porcine Dermis vs. Strattice™ Reconstructive Tissue Matrix in Patients Undergoing Complex Open Primary Ventral Hernia Repair
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: