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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synthetic Mesh | Active Comparator | Synthetic mesh (mid-density polypropylene (generic) Bard soft mesh) will be used in open ventral hernia repair |
|
| Biologic Mesh | Active Comparator | Biologic mesh (non cross linked porcine acellular dermal matrix: Strattice) will be used in open ventral hernia repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synthetic Mesh | Device | Synthetic mesh used during open ventral hernia repair |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie L Holihan, M.D. | UT Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health at Lyndon B. Johnson General Hospital | Houston | Texas | 77026 | United States |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Biologic Mesh |
| Device |
Biologic mesh used during open ventral hernia repair |
|
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 |