Large Abdominal Hernia Repair With SurgiMend 3.0 (BRIDGE)

Integra LifeSciences

Status: Completed

Conditions: Hernia

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00892333

TEI-002

Details and patient eligibility

About

The rate of hernia recurrence at one year following repair of a large abdominal hernia with a biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of 40%. The purpose of this study is to evaluate the rate of hernia recurrence at one year following repair with SurgiMend 3.0, an FDA-cleared novel biologic mesh, the hypothesis being that such rate will be less than 20% at one year, representing a 50% reduction over the historic rate of 40%.

Enrollment: 122 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All three of the following criteria must be present for enrollment into the study:

• Large abdominal hernia
• Inability to close the fascia primarily
• Contra-indication for the use of synthetic mesh
• Age > 18 years

Exclusion criteria

• Use of SurgiMend 3.0 to simply reinforce a complete closure of the fascia performed either primarily or sequentially or by component separation technique
• Inability to close the skin over the SurgiMend 3.0