A Comparison of the Outcomes in Fortiva and Strattice Mesh

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05572021
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22
• Patients Per Site Per Month: 9.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ventral Hernia	Device: Propspective VHR with Fortiva; Device: RetroSpective VHR with Strattice	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Comparison of prospective group to retrospective groupComparison of prospective group to retrospective group
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparison of the Outcomes in Fortiva and Strattice Mesh
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Frequency of participants with a Hernia recurrence [1 year follow up post surgical repair]

   Frequency of participants with a hernia recurrence

2. Percent of participants with a Hernia recurrence [1 year follow up post surgical repair]

   Percent of participants with a hernia recurrence

Secondary Outcome Measures

1. Frequency of participants with a Mesh related complication [1 year follow up post surgical repair]

   Frequency of participants with a mesh related complication

2. Percent of participants with a Mesh related complication [1 year follow up post surgical repair]

   Percent of participants with a mesh related complication

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ventral Hernia requiring surgical repair

Exclusion Criteria:

• Pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carolinas Medical Center	Charlotte	North Carolina	United States	28204

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT05572021
• Other Study ID Numbers: IRB00088523
• First Posted: Oct 7, 2022
• Last Update Posted: Feb 2, 2023
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Wake Forest University Health Sciences: ventral hernia; surgical biologic mesh; hernia complications
• Additional relevant MeSH terms: Hernia; Hernia, Ventral

Study Results

No Results Posted as of Feb 2, 2023