NCT05572021

A Comparison of the Outcomes in Fortiva and Strattice Mesh

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-25
• Primary completion: 2025-03-21
• Completion: 2025-03-21
• First posted: 2022-10-07
• Last updated: 2025-10-28
• Results posted: 2025-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study