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

Cook County Hosp

1900 W Polk St
Chicago, Illinois 60612

from

Chicago, IL