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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Fortiva Porcine Dermis implantation during repair of complex ventral hernia
Strattice tissue matrix implanted during repair of complex ventral hernia
Washington University
St Louis, Missouri, United States
The Proportion of Patients Who Experience a True Hernia Recurrence
True hernia recurrence as diagnosed by physical exam or CT scan
Time frame: 12 months
SF-36 MCS
SF-36 mental component summary scale ranges from 0-100. Higher score indicates better self reported health.
Time frame: 3 months
Pain Measured Using the Visual Analog Scale for Pain
Visual analog scale measures extremes of pain on a scale from 0-10. 0 is no pain and 10 is worst pain
Time frame: 3 months
True Recurrence at 24 Months
Time frame: 24 months
Time to Discharge
Time is from date of procedure to date of each patient discharge. Mean of each group is provided
Time frame: Discharge
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