Veritas in Non-Bridging Ventral Hernia Repair (VIBE)

Baxter

Status: Terminated

Conditions: Hernia

Study type: Observational

Funder types: Industry

Identifiers

NCT01426477

09-004

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Veritas Collagen Matrix

Description:

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