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NCT05572021 Clinical Trial

A Comparison of the Outcomes in Fortiva and Strattice Mesh

Ventral Hernia Clinical Trial

Official title:
A Comparison of the Outcomes in Fortiva and Strattice Mesh

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05572021
Other study ID # IRB00088523
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 25, 2023
Est. completion date February 2025

Study information
Verified date October 2023
Source Wake Forest University Health Sciences
Contact Gregory T Scarola, MS
Phone 704-355-5379
Email Gregory.Scarola@Atriumhealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Ventral Hernia requiring surgical repair Exclusion Criteria: - Pregnant women

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Propspective VHR with Fortiva
Ventral hernia repair using Fortiva biologic mesh
• RetroSpective VHR with Strattice
Retrospective cohort of ventral hernia repair patients using Strattice mesh

Locations
Country Name City State
United States Carolinas Medical Center Charlotte North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of participants with a Hernia recurrence Frequency of participants with a hernia recurrence 1 year follow up post surgical repair
Primary Percent of participants with a Hernia recurrence Percent of participants with a hernia recurrence 1 year follow up post surgical repair
Secondary Frequency of participants with a Mesh related complication Frequency of participants with a mesh related complication 1 year follow up post surgical repair
Secondary Percent of participants with a Mesh related complication Percent of participants with a mesh related complication 1 year follow up post surgical repair
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