A Comparison of the Outcomes in Fortiva and Strattice Mesh

Wake Forest University (WFU)

Status: Enrolling

Conditions: Ventral Hernia

Treatments: Device: Propspective VHR with Fortiva; Device: RetroSpective VHR with Strattice

Study type: Interventional

Funder types: Other

Identifiers

NCT05572021

IRB00088523

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ventral Hernia requiring surgical repair

Exclusion criteria

• Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Prospective

Experimental group

Description:

Participants enrolled to ventral hernia repair with Fortiva mesh

Treatment:

Device: Propspective VHR with Fortiva

Retrospective

Active Comparator group

Description:

Retrospective participants with ventral hernia repair using Strattice mesh

Treatment:

Device: RetroSpective VHR with Strattice