Veritas in Non-Bridging Ventral Hernia Repair (VIBE)

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

Study Overview

• Status: Terminated
• Conditions: Hernia

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Department of Surgery
    • Lakeland, Florida, United States, 33805
      • Watson Clinic Center for Research
  • Georgia
    • Atlanta, Georgia, United States, 30274
      • Atlanta Colon & Rectal Surgery, P.A.
  • Virginia
    • Fredericksburg, Virginia, United States, 22407
      • Pratt Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study surgeons will recruit patients from within their own practice, or through their typical referring sources.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia recurrence	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.	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Medical and Surgical Complications	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 years
Change in Quality of Life	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.	Baseline to 2 Years

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Synovis Surgical Innovations

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: August 29, 2011
• First Submitted That Met QC Criteria: August 30, 2011
• First Posted (Estimate): August 31, 2011

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Ventral hernia; Incisional hernia; Biologic mesh; Veritas; Abdominal wall hernia; Veritas Collagen Matrix
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: 09-004