Large Abdominal Hernia Repair With SurgiMend 3.0

Integra LifeSciences Corporation122 enrolled

Overview

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%.

Study Type

OBSERVATIONAL

Enrollment

122

Conditions

Hernia

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (8)

Los Angeles County/University of Southern California Medical Center

Los Angeles, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Cook County Hospital

Chicago, Illinois, United States

Massachusetts General Hospital

Outcomes

Primary Outcomes

Hernia recurrence

Time frame: 1 year

Data from ClinicalTrials.gov

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