Hernia
Conditions
Keywords
Ventral hernia, Abdominal wall hernia, Incisional hernia, Biologic mesh, Veritas Collagen Matrix, Veritas
Brief summary
The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.
Interventions
None listed
Sponsors
Synovis Surgical Innovations
Baxter Healthcare Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia recurrence | 2 Years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Medical and Surgical Complications | 2 years | 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. |
| Change in Quality of Life | Baseline to 2 Years | 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. |
Countries
United States
Outcome results
None listed