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Veritas in Non-Bridging Ventral Hernia Repair (VIBE)

This study is currently recruiting participants.
Verified April 2012 by Synovis Surgical Innovations
Sponsor:
Information provided by (Responsible Party):
Synovis Surgical Innovations
ClinicalTrials.gov Identifier:
NCT01426477
First received: August 29, 2011
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  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:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Synovis Surgical Innovations:

Primary Outcome Measures:
  • Hernia recurrence [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    Recurrence will be evaluated through physical exam and/or CT scans at all study visits (30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years), or when patients present with symptoms, with primary endpoint at 5 years.


Secondary Outcome Measures:
  • Number of Medical and Surgical Complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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, 2 years, 3 years, 4 years and 5 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 5 Years ] [ Designated as safety issue: No ]
    Patients will complete questionnaires regarding physical functioning including activities of daily living, work productivity, and patient comfort at vartious timepoints after implant at baseline, and at all follow-up visits. Outcomes will be reported in the change from baseline to 5-years.


Estimated Enrollment: 100
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
Genders Eligible for Study:   Both
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
  • 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
  • Sensitivity to bovine products
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426477

Contacts
Contact: Lisa Draper 651-796-7511 lisa.draper@synovissurgical.com

Locations
United States, Florida
Watson Clinic Center for Research Recruiting
Lakeland, Florida, United States, 33805
United States, Georgia
Atlanta Colon & Rectal Surgery, P.A. Recruiting
Atlanta, Georgia, United States, 30274
Sponsors and Collaborators
Synovis Surgical Innovations
  More Information

No publications provided

Responsible Party: Synovis Surgical Innovations
ClinicalTrials.gov Identifier: NCT01426477     History of Changes
Other Study ID Numbers: 09-004
Study First Received: August 29, 2011
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Synovis Surgical Innovations:
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 May 19, 2013