N/A
N=120
A Comparison of Fortiva and Strattice Tissue Matrices in Complex, Ventral Hernia Repair
Ventral Hernia
Bottom Line
View on ClinicalTrials.gov: NCT02587403 ↗Enrolled (actual)
120
Serious AEs
30.0%
Results posted
Dec 2024
Primary outcome: Primary: The Proportion of Patients Who Experience a True Hernia Recurrence — 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fortiva™ Porcine Dermis (Device); Strattice™ Reconstructive Tissue Matrix (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- RTI Surgical
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Patients Who Experience a True Hernia Recurrence |
2; 1 | — |
| SECONDARY SF-36 MCS |
48.9; 48.9 | — |
| SECONDARY Pain Measured Using the Visual Analog Scale for Pain |
2.41; 2.37 | — |
| SECONDARY True Recurrence at 24 Months |
3; 1 | — |
| SECONDARY Time to Discharge |
7.93; 8.11 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or greater
- Have a BMI 40
- Have a hernia estimated to be /=100mg of prednisone) within the past 6 weeks
- Known tobacco use within the past 6 weeks or positive serum cotinine test at time of admission
- Uncontrolled diabetes (i.e. known HbA1C value > 7% within the last 6 weeks)
- History of drug addiction (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or the subject's ability to complete the required follow up
- Pregnancy and/or breastfeeding
- Enterocutaneous fistula
- Ventral hernia repairs involving active infection
- Inability to obtain primary fascial closure (Intra-operatively)
- Planned use of external VAC dressing intra-operatively
Data sourced from ClinicalTrials.gov (NCT02587403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.