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

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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
7
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
2578
mi
from 91732
Boston, MA
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1 Boston Medical Center Pl
Boston, Massachusetts 02118
617.638.8000
Boston Med Center Boston Medical Center (BMC) is a 496-bed academic medical center located in...
2578
mi
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Boston, MA
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1900 W Polk St
Chicago, Illinois 60612
1727
mi
from 91732
Chicago, IL
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11
mi
from 91732
Los Angeles, CA
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
2486
mi
from 91732
New Haven, CT
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826
mi
from 91732
Portland, OR
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2319
mi
from 91732
Syracuse, NY
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