A Comparison of the Outcomes in Fortiva and Strattice Mesh

Last updated: February 24, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Pentalogy Of Cantrell

Treatment

RetroSpective VHR with Strattice

Propspective VHR with Fortiva

Clinical Study ID

NCT05572021
IRB00088523
  • Ages 18-100
  • All Genders

Study Summary

A comparison of ventral hernia repair with Strattice and Fortiva mesh.Primary The study team aims to determine the hernia recurrence rates for RTI Surgical biologic mesh (Fortiva) compared to Strattice. Also the study team aims to determine the mesh related complications for RTI Surgical biologic mesh (Fortiva) compared to Strattice

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ventral Hernia requiring surgical repair

Exclusion

Exclusion Criteria:

  • Pregnant women

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: RetroSpective VHR with Strattice
Phase:
Study Start date:
September 25, 2023
Estimated Completion Date:
February 28, 2026

Study Description

This study will be a prospective, matched study of patients using Fortiva biologic mesh to determine the rates of hernia recurrence and mesh related complication compared to Strattice mesh. Patients who meet the inclusion and exclusion criteria will be prospectively enrolled to receive a Ventral Hernia Repair (VHR) using Fortiva biologic mesh and will be compared to a retrospective cohort of patients with a VHR that utilized Strattice mesh. Patients will be propensity matched in a 1:3 (Fortiva : Strattice) fashion based on age, sex, and hernia defect size.

Connect with a study center

  • Carolinas Medical Center

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

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