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

Not Applicable

Completed

Conditions: Ventral Hernia

Interventions: Device: Fortiva™ Porcine Dermis
Device: Strattice™ Reconstructive Tissue Matrix

Registration Number: NCT02587403

Lead Sponsor: RTI Surgical

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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 Patients whose defects do NOT meet or exceed 200 cm2 intra-operatively will be withdrawn from the study and will be considered an intra-operative screen failure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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fortiva™ Porcine Dermis	Fortiva™ Porcine Dermis	Fortiva Porcine Dermis implantation during repair of complex ventral hernia
Strattice™ Reconstructive Tissue Matrix	Strattice™ Reconstructive Tissue Matrix	Strattice tissue matrix implanted during repair of complex ventral hernia

Primary Outcome Measures

Name	Time	Method
The Proportion of Patients Who Experience a True Hernia Recurrence	12 months	True hernia recurrence as diagnosed by physical exam or CT scan

Secondary Outcome Measures

Name	Time	Method
SF-36 MCS	3 months	SF-36 mental component summary scale ranges from 0-100. Higher score indicates better self reported health.
Pain Measured Using the Visual Analog Scale for Pain	3 months	Visual analog scale measures extremes of pain on a scale from 0-10. 0 is no pain and 10 is worst pain
True Recurrence at 24 Months	24 months
Time to Discharge	Discharge	Time is from date of procedure to date of each patient discharge. Mean of each group is provided