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

NCT02587403 | Completed Results

• 1 other identifier: RTI-2015-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• The Proportion of Patients Who Experience a True Hernia Recurrence

  True hernia recurrence as diagnosed by physical exam or CT scan

  12 months

Secondary Outcomes (4)

• SF-36 MCS

  3 months

• Pain Measured Using the Visual Analog Scale for Pain

  3 months

• True Recurrence at 24 Months

  24 months

• Time to Discharge

  Discharge

Study Arms (2)

Fortiva™ Porcine Dermis

ACTIVE COMPARATOR

Fortiva Porcine Dermis implantation during repair of complex ventral hernia

Device: Fortiva™ Porcine Dermis

Strattice™ Reconstructive Tissue Matrix

ACTIVE COMPARATOR

Strattice tissue matrix implanted during repair of complex ventral hernia

Device: Strattice™ Reconstructive Tissue Matrix

Interventions

Fortiva™ Porcine Dermis DEVICE

Fortiva Porcine Dermis implantation during repair of complex ventral hernia

Fortiva™ Porcine Dermis

Strattice™ Reconstructive Tissue Matrix DEVICE

Strattice tissue matrix implanted during repair of complex ventral hernia

Strattice™ Reconstructive Tissue Matrix

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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 Patients whose defects do NOT meet or exceed 200 cm2 intra-operatively will be withdrawn from the study and will be considered an intra-operative screen failure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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• RTI Surgical: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jennifer Johnson, Senior Clinical Manager
• Organization: RTI Surgical

jljohnson@rtix.com

386-418-8888

Study Officials

• Grant Bochicchio, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 27, 2015
• Study Start: December 2, 2015
• Primary Completion: September 19, 2023
• Study Completion: September 19, 2023
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)