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

NCT ID: NCT02587403

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-02
• Study Completion Date: 2023-09-19

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.

Conditions

Ventral Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fortiva™ Porcine Dermis

Fortiva Porcine Dermis implantation during repair of complex ventral hernia

Group Type: ACTIVE_COMPARATOR

Fortiva™ Porcine Dermis

Intervention Type: DEVICE

Fortiva Porcine Dermis implantation during repair of complex ventral hernia

Strattice™ Reconstructive Tissue Matrix

Strattice tissue matrix implanted during repair of complex ventral hernia

Group Type: ACTIVE_COMPARATOR

Strattice™ Reconstructive Tissue Matrix

Intervention Type: DEVICE

Strattice tissue matrix implanted during repair of complex ventral hernia

Interventions

Fortiva™ Porcine Dermis

Fortiva Porcine Dermis implantation during repair of complex ventral hernia

Intervention Type: DEVICE

Strattice™ Reconstructive Tissue Matrix

Strattice tissue matrix implanted during repair of complex ventral hernia

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RTI Surgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grant Bochicchio, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RTI-2015-02

Identifier Type: -

Identifier Source: org_study_id