Veritas in Non-Bridging Ventral Hernia Repair

Terminated

• Conditions: Hernia

• Registration Number: NCT01426477
• Lead Sponsor: Baxter Healthcare Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-29
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-08-31
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

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