Repair of Infected or Contaminated Hernias

Status:	Completed
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	September 2007
End Date:	December 2010

A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM

This is a prospective, multicenter, interventional, observational, open label, single arm,
longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or
infected sites. Three interim analyses are planned to examine the incidence of surgical site
events, postoperative resumption of activities and hernia recurrence.

Inclusion Criteria:

- is an adult ≥18 years old.

- has need of open abdominal incisional repair of a contaminated or infected site

- has an estimated hernia size of >9cm2 by physical exam

Exclusion Criteria:

- has a nidus of chronic colonization

- has a systemic infection at the time of repair.

- has chronic conditions: hepatic cirrhosis (w/ or w/o ascites); renal failure w/ hemo-
or peritoneal dialysis; incomplete resection of malignant disease; or defined
collagen disorder.

- requires chronic immunosuppressive therapy, including steroids or cytotoxic agents.

- is bedridden or otherwise non-ambulatory.

- is ASA Class 4 or 5.

- has a BMI >40.

- has conditions that would adversely affect subject safety, as per product labeling,
including sensitivities to pork or porcine products.

We found this trial at

sites

Hospital of St Rafael

New Haven, Connecticut

from

New Haven, CT