A Comparison of the Outcomes in Fortiva and Strattice Mesh

October 13, 2025 updated by: Wake Forest University Health Sciences
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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ventral Hernia requiring surgical repair

Exclusion Criteria:

  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prospective
Participants enrolled to ventral hernia repair with Fortiva mesh
Device: Prospective Ventral Hernia Repair with Fortiva
Ventral hernia repair using Fortiva biologic mesh
Active Comparator: Retrospective
Retrospective participants with ventral hernia repair using Strattice mesh
Device: RetroSpective Ventral Hernia Repair with Strattice
Retrospective cohort of ventral hernia repair patients using Strattice mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Participants With a Hernia Recurrence
Time Frame: 1 year follow up post surgical repair
Frequency of participants with a hernia recurrence
1 year follow up post surgical repair
Percentage of Participants With a Hernia Recurrence
Time Frame: 1 year follow up post surgical repair
Percentage of participants with a hernia recurrence
1 year follow up post surgical repair

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a Mesh Related Complication
Time Frame: 1 year follow up post surgical repair
Number of participants with a mesh related complication
1 year follow up post surgical repair
Percent of Participants With a Mesh Related Complication
Time Frame: 1 year follow up post surgical repair
Percent of participants with a mesh related complication
1 year follow up post surgical repair

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Todd Heniford, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Actual)

March 21, 2025

Study Completion (Actual)

March 21, 2025

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Estimated)

October 28, 2025

Last Update Submitted That Met QC Criteria

October 13, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00088523

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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