Status:
TERMINATED
Veritas in Non-Bridging Ventral Hernia Repair
Lead Sponsor:
Baxter Healthcare Corporation
Collaborating Sponsors:
Synovis Surgical Innovations
Conditions:
Hernia
Eligibility:
All Genders
18+ years
Brief Summary
The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01426477
Start Date
August 1 2011
End Date
August 1 2017
Last Update
January 23 2018
Active Locations (4)
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1
Mayo Clinic Department of Surgery
Jacksonville, Florida, United States, 32224
2
Watson Clinic Center for Research
Lakeland, Florida, United States, 33805
3
Atlanta Colon & Rectal Surgery, P.A.
Atlanta, Georgia, United States, 30274
4
Pratt Medical Center
Fredericksburg, Virginia, United States, 22407