Large Abdominal Hernia Repair With SurgiMend 3.0

Completed

Conditions studied: Hernia

In brief

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%.

Key facts

Study ID

NCT00892333

Run by

Integra LifeSciences Corporation

People needed

122

Starts

2009-04-01

Expected to finish

2014-07-01

Last updated by the study team

2016-05-17

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• State University of New York (SUNY), Upstate Medical Center — Syracuse, New York, United States
• Oklahoma University — Oklahoma City, Oklahoma, United States
• Oregon Health and Science University (OHSU) — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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