Veritas in Non-Bridging Ventral Hernia Repair (VIBE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01426477
Recruitment Status : Terminated
First Posted : August 31, 2011
Last Update Posted : January 23, 2018
Synovis Surgical Innovations
Information provided by (Responsible Party):
Baxter Healthcare Corporation

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

Condition or disease

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Veritas in Non-Bridging Ventral Hernia Repair
Study Start Date : August 2011
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Veritas Collagen Matrix
Observational study of subjects who undergo open ventral hernia repair using Veritas Collagen Matrix in an underlay technique.

Primary Outcome Measures :
  1. Hernia recurrence [ Time Frame: 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 :
  1. Number of Medical and Surgical Complications [ Time Frame: 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.

  2. Change in Quality of Life [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study surgeons will recruit patients from within their own practice, or through their typical referring sources.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01426477

United States, Florida
Mayo Clinic Department of Surgery
Jacksonville, Florida, United States, 32224
Watson Clinic Center for Research
Lakeland, Florida, United States, 33805
United States, Georgia
Atlanta Colon & Rectal Surgery, P.A.
Atlanta, Georgia, United States, 30274
United States, Virginia
Pratt Medical Center
Fredericksburg, Virginia, United States, 22407
Sponsors and Collaborators
Baxter Healthcare Corporation
Synovis Surgical Innovations

Responsible Party: Baxter Healthcare Corporation Identifier: NCT01426477     History of Changes
Other Study ID Numbers: 09-004
First Posted: August 31, 2011    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by Baxter Healthcare Corporation:
Ventral hernia
Abdominal wall hernia
Incisional hernia
Biologic mesh
Veritas Collagen Matrix

Additional relevant MeSH terms:
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal