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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ventral Hernia

Intervention / Treatment
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* Device: Fortiva™ Porcine Dermis
* Device: Strattice™ Reconstructive Tissue Matrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or greater Have a BMI < or equal to 40 Have a pre-operative estimated hernia defect of 200 cm2 OR multiple hernia defects whose combined area is ≥ an estimated 200 cm2. Patients whose defects do NOT meet or exceed 200 cm2 intra-operatively will be withdrawn from the study and will be considered an intra-operative screen failure Have no contraindications to the test material (s) Have a life expectancy greater than 1 year in the opinion of the Investigator Able to provide informed consent Able and willing to return for scheduled study visits over 2 years post-operatively (following research related surgery) Exclusion Criteria: < 18 years of age Subject is determined to have an American Society of Anesthesiologists'(ASA) physical class of 4, 5, or 6 Have a BMI >40 Have a hernia estimated to be <200 cm2 Have abdominal loss of domain such that the operation would be impractical or would adversely affect respiratory or cardiovascular function to an unacceptable degree in the opinion of the investigator Inability to close the fascia primarily without abdominal wall mobilization or component separation Participation in an investigational drug or device study that would impact the safety or scientific integrity of this study (in the opinion of the Investigator and with the approval of the Sponsor) within the past 6 weeks prior to enrollment into this trial Have active necrotizing fasciitis or any other known active local or systemic infection Have a known collagen metabolism disorder or any medical condition that could interfere with normal tissue healing process as determined by the Investigator Have a known active malignancy present and/or had chemotherapy 12 weeks prior to screening or planned chemotherapy within 12 weeks of enrollment with exception of BCC or SCC Have known moderate to severe cirrhosis which in the opinion of the Investigator would impact the outcome of this trial Have a life expectancy less than 1 year Be unable to participate in the informed consent process Be unable or unwilling to return for scheduled study visits over the 2 year post-operative assessment period Received high dose steroids (>/=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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fortiva™ Porcine Dermis<br>Fortiva Porcine Dermis implantation during repair of complex ventral hernia | Device: Fortiva™ Porcine Dermis<br>* Fortiva Porcine Dermis implantation during repair of complex ventral hernia<br>|
| Active Comparator: Strattice™ Reconstructive Tissue Matrix<br>Strattice tissue matrix implanted during repair of complex ventral hernia | Device: Strattice™ Reconstructive Tissue Matrix<br>* Strattice tissue matrix implanted during repair of complex ventral hernia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who experience a true hernia recurrence |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction (using the SF-36 questionnaire) |  | Baseline, 3 months, 6 months, 12, and 24 months | 
| Pain measured using the Visual Analog Scale for Pain |  | Baseline, 3 months, 6 months, 12, and 24 months | 
| Type of Adverse Events (volunteered and elicited) |  | 3 months, 6 months, 12, and 24 months |