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Veritas in Non-Bridging Ventral Hernia Repair (VIBE)

This study has been terminated.
Sponsor:
Collaborator:
Synovis Surgical Innovations
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01426477
First received: August 29, 2011
Last updated: April 4, 2017
Last verified: April 2017
  Purpose
The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.

Condition
Hernia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Veritas in Non-Bridging Ventral Hernia Repair

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.


Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Veritas Collagen Matrix
Observational study of subjects who undergo open ventral hernia repair using Veritas Collagen Matrix in an underlay technique.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426477

Locations
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
  More Information

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01426477     History of Changes
Other Study ID Numbers: 09-004
Study First Received: August 29, 2011
Last Updated: April 4, 2017

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

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

ClinicalTrials.gov processed this record on April 27, 2017