Repair of Large Abdominal Hernia Defects By A Novel Biologic Mesh: A Prospective Multi-Center Observational Study

Conditions:		Hernia
Purpose:		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 Summary:
Criteria:		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
NCT ID:		NCT00892333
Primary Contact:		Principal Investigator George C Velmahos, MD, Ph.D. Massachusetts General Hospital/ Harvard University
Backup Contact:		N/A
Location Contact:		Syracuse, New York 13210 United States Moustafa Hassan, M.D. Email: hassanm@upstate.edu Site Status: Recruiting

Data Source:		ClinicalTrials.gov
Date Processed:		May 18, 2013
Modifications to this listing:		Only selected fields are shown, please use the link below to view all information about this clinical trial.
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