Large Abdominal Hernia Repair With SurgiMend 3.0 (LAHRS 3.0)

Status:	Completed
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	19 - Any
Updated:	10/2/2013
Start Date:	April 2009
End Date:	September 2013

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

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%.

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

We found this trial at

sites

State University of New York (SUNY), Upstate Medical Center

Syracuse, New York 13210

from

Syracuse, NY