Large Abdominal Hernia Repair With SurgiMend 3.0

Conditions

Hernia

What is the purpose of this trial?

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%.



Participation Guidelines

Age:
19 Years and older
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
Boston Medical Center
Cook County Hospital
Massachusetts General Hospital
Oregon Health and Science University
State University of New York - Upstate Medical University
TEI Biosciences Inc.
University of Southern California
Yale University
Dates:
July 2010
Last Updated:
September 27, 2013
Study HIC#:
1005006844

Clinicaltrials.gov ID: NCT00892333