A Comparison of the Outcomes in Fortiva and Strattice Mesh
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Frequency of Participants With a Hernia Recurrence
Study Overview
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
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
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ventral Hernia requiring surgical repair
Exclusion Criteria
- •Pregnant women
Arms & Interventions
Prospective
Participants enrolled to ventral hernia repair with Fortiva mesh
Intervention: Prospective Ventral Hernia Repair with Fortiva (Device)
Retrospective
Retrospective participants with ventral hernia repair using Strattice mesh
Intervention: RetroSpective Ventral Hernia Repair with Strattice (Device)
Outcomes
Primary Outcomes
Frequency of Participants With a Hernia Recurrence
Time Frame: 1 year follow up post surgical repair
Frequency of participants with a hernia recurrence
Percentage of Participants With a Hernia Recurrence
Time Frame: 1 year follow up post surgical repair
Percentage of participants with a hernia recurrence
Secondary Outcomes
- Number of Participants With a Mesh Related Complication(1 year follow up post surgical repair)
- Percent of Participants With a Mesh Related Complication(1 year follow up post surgical repair)