Veritas in Non-Bridging Ventral Hernia Repair

Hernia Clinical Trial

— VIBE  

Official title:

Veritas in Non-Bridging Ventral Hernia Repair

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01426477
• Other study ID #: 09-004
• Status: Terminated
• Phase: N/A
• First received: August 29, 2011
• Last updated: January 18, 2018
• Start date: August 2011
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral

Locations

Country	Name	City	State
United States	Atlanta Colon & Rectal Surgery, P.A.	Atlanta	Georgia
United States	Pratt Medical Center	Fredericksburg	Virginia
United States	Mayo Clinic Department of Surgery	Jacksonville	Florida
United States	Watson Clinic Center for Research	Lakeland	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Synovis Surgical Innovations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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