A Comparison of the Outcomes in Fortiva and Strattice Mesh

Not Applicable

Recruiting

• Conditions: Ventral Hernia
• Interventions: Device: RetroSpective VHR with Strattice; Device: Propspective VHR with Fortiva

• Registration Number: NCT05572021
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-07
• Study Start: 2023-09-25
• Status Verified: 2024-09
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Ventral Hernia requiring surgical repair

Exclusion Criteria

• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Retrospective	RetroSpective VHR with Strattice	Retrospective participants with ventral hernia repair using Strattice mesh
Prospective	Propspective VHR with Fortiva	Participants enrolled to ventral hernia repair with Fortiva mesh

Primary Outcome Measures

Name	Time	Method
Frequency of participants with a Hernia recurrence	1 year follow up post surgical repair	Frequency of participants with a hernia recurrence
Percent of participants with a Hernia recurrence	1 year follow up post surgical repair	Percent of participants with a hernia recurrence

Secondary Outcome Measures

Name	Time	Method
Frequency of participants with a Mesh related complication	1 year follow up post surgical repair	Frequency of participants with a mesh related complication
Percent of participants with a Mesh related complication	1 year follow up post surgical repair	Percent of participants with a mesh related complication

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States