A Comparison of the Outcomes in Fortiva and Strattice Mesh

NCT ID: NCT05572021

Last Updated: 2025-10-28

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-25

Study Completion Date

2025-03-21

Brief Summary

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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

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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.

Conditions

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Ventral Hernia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Comparison of prospective group to retrospective group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prospective

Participants enrolled to ventral hernia repair with Fortiva mesh

Group Type EXPERIMENTAL

Prospective Ventral Hernia Repair with Fortiva

Intervention Type DEVICE

Ventral hernia repair using Fortiva biologic mesh

Retrospective

Retrospective participants with ventral hernia repair using Strattice mesh

Group Type ACTIVE_COMPARATOR

RetroSpective Ventral Hernia Repair with Strattice

Intervention Type DEVICE

Retrospective cohort of ventral hernia repair patients using Strattice mesh

Interventions

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Prospective Ventral Hernia Repair with Fortiva

Ventral hernia repair using Fortiva biologic mesh

Intervention Type DEVICE

RetroSpective Ventral Hernia Repair with Strattice

Retrospective cohort of ventral hernia repair patients using Strattice mesh

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Ventral Hernia requiring surgical repair

Exclusion Criteria

* Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Todd Heniford, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00088523

Identifier Type: -

Identifier Source: org_study_id

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