Veritas in Non-Bridging Ventral Hernia Repair

Study Overview
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Brief Summary
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The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.

Official Title
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Veritas in Non-Bridging Ventral Hernia Repair

Conditions
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Hernia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be 18 years of age or older Ability to understand and read English Must be scheduled for open abdominal surgery for repair of primary ventral hernia or first recurrence of a ventral hernia with the Veritas Collagen Matrix using the underlay technique, with our without component separation Must be of ambulatory status Primary closure can be obtained during surgery Repair is such that one piece of Veritas can be used to reinforce the repair Exclusion Criteria: Hernia is undetectable on physical exam There is evidence of existing cancer BMI ≥ 40 Use of chronic immunosuppressive therapy, including steroids or cytotoxic agents Any condition that product labeling indicates would adversely affect participant safety, including sensitivity to bovine products

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Veritas Collagen Matrix<br>Observational study of subjects who undergo open ventral hernia repair using Veritas Collagen Matrix in an underlay technique. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia recurrence | Recurrence will be evaluated through physical exam and/or CT scans at all study visits (30 days, 6 months, 1 year, and 2 years), or when patients present with symptoms, with primary endpoint at 2 years. | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Medical and Surgical Complications | Medical and Surgical Complications, including seroma, wound infection or other concurrent infection, hematoma, fistula, ileus, skin necrosis, wound dehiscence, or any other device-related events, will be evaluated through physical exam and/or CT scans at 30 days, 6 months, 1 year, and 2 years, or when patients present with symptoms. These will be reported as total number of each complication within the total number of patients. | 2 years | 
| Change in Quality of Life | Patients will complete questionnaires regarding physical functioning including activities of daily living, work productivity, and patient comfort at various timepoints after implant at baseline, and at all follow-up visits. Outcomes will be reported in the change from baseline to 2-years. | Baseline to 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventral hernia, Abdominal wall hernia, Incisional hernia, Biologic mesh, Veritas Collagen Matrix, Veritas