A Comparison of the Outcomes in Fortiva and Strattice Mesh

Study Overview
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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.

Official Title
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A Comparison of the Outcomes in Fortiva and Strattice Mesh

Conditions
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Ventral Hernia

Intervention / Treatment
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* Device: Propspective VHR with Fortiva
* Device: RetroSpective VHR with Strattice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ventral Hernia requiring surgical repair Exclusion Criteria: Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Comparison of prospective group to retrospective group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective<br>Participants enrolled to ventral hernia repair with Fortiva mesh | Device: Propspective VHR with Fortiva<br>* Ventral hernia repair using Fortiva biologic mesh<br>|
| Active Comparator: Retrospective<br>Retrospective participants with ventral hernia repair using Strattice mesh | Device: RetroSpective VHR with Strattice<br>* Retrospective cohort of ventral hernia repair patients using Strattice mesh<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of participants with a Hernia recurrence | Frequency of participants with a hernia recurrence | 1 year follow up post surgical repair | 
| Percent of participants with a Hernia recurrence | Percent of participants with a hernia recurrence | 1 year follow up post surgical repair | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of participants with a Mesh related complication | Frequency of participants with a mesh related complication | 1 year follow up post surgical repair | 
| Percent of participants with a Mesh related complication | Percent of participants with a mesh related complication | 1 year follow up post surgical repair | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventral hernia, surgical biologic mesh, hernia complications