Mesh Type in Ventral Hernia Repair

Study Overview
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Brief Summary
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Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half are repaired using biologic mesh while half are repaired using synthetic mesh. The investigators hypothesize that biologic mesh as opposed to synthetic mesh repair of open ventral hernia repair is associated with decreased risk of major complications one year after surgery.

Official Title
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Mesh Type in Ventral Hernia Repair

Conditions
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Ventral Hernia

Intervention / Treatment
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* Device: Synthetic Mesh
* Device: Biologic Mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for open ventral hernia repair at LBJ General Hospital Exclusion Criteria: Active infection Patient unlikely to survive with the next 2 years based upon surgeon judgment (i.e. metastatic cancer, end-stage cirrhosis) Patient surgeon would not normally place a prosthetic (e.g. planned second surgery such as ostomy takedown) Patient unlikely to follow-up (i.e. no phone)

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Synthetic Mesh<br>Synthetic mesh (mid-density polypropylene (generic) Bard soft mesh) will be used in open ventral hernia repair | Device: Synthetic Mesh<br>* Synthetic mesh used during open ventral hernia repair<br>|
| Active Comparator: Biologic Mesh<br>Biologic mesh (non cross linked porcine acellular dermal matrix: Strattice) will be used in open ventral hernia repair | Device: Biologic Mesh<br>* Biologic mesh used during open ventral hernia repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication free at 1 year post-operative | Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication free at 3 years post-operative | Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation | 3 years after surgery | 
| Dindo-clavien complications | Grade I to V | Pre-operative, 1 month after surgery, 1 year and 3 years after surgery | 
| Patient centered outcomes | includes patient satisfaction, cosmetic satisfaction, modified assessment scale | Pre-operative, 1 month after surgery, 1 year and 3 years after surgery | 
| Cost | charges for all patient visits, admissions, and procedures | 1 year and 3 years after surgery | 

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