Veritas in Non-Bridging Ventral Hernia Repair

N/ATerminatedNCT01426477

Baxter Healthcare Corporation20 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hernia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Mayo Clinic Department of Surgery

Jacksonville, Florida, United States

Watson Clinic Center for Research

Lakeland, Florida, United States

Atlanta Colon & Rectal Surgery, P.A.

Atlanta, Georgia, United States

Pratt Medical Center

Fredericksburg, Virginia, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 Years

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline to 2 Years

Data from ClinicalTrials.gov

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