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A Comparison of the Outcomes in Fortiva and Strattice Mesh

NCT05572021 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-10-28

Study results available
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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

Conditions

  • Ventral Hernia

Interventions

DEVICE

Prospective Ventral Hernia Repair with Fortiva

Ventral hernia repair using Fortiva biologic mesh

DEVICE

RetroSpective Ventral Hernia Repair with Strattice

Retrospective cohort of ventral hernia repair patients using Strattice mesh

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Todd Heniford, MD · Wake Forest University Health Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2025-03-21
Completion
2025-03-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05572021 on ClinicalTrials.gov