Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
20 participants
OBSERVATIONAL
2011-08-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Veritas Collagen Matrix
Observational study of subjects who undergo open ventral hernia repair using Veritas Collagen Matrix in an underlay technique.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Synovis Surgical Innovations
INDUSTRY
Baxter Healthcare Corporation
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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09-004
Identifier Type: -
Identifier Source: org_study_id
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