Repair of Infected or Contaminated Hernias

Completed · Not applicable

Conditions studied: Hernia

In brief

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.

Key facts

Study ID

NCT00617357

Run by

LifeCell

People needed

83

Starts

2007-09-01

Expected to finish

2010-12-01

Last updated by the study team

2015-12-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California-San Diego Medical Center — La Jolla, California, United States
• Hospital of St Rafael — New Haven, Connecticut, United States
• Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States
• Tulane University Medical Center — New Orleans, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• University of Missouri-Columbia Medical Center — Columbia, Missouri, United States
• Washington University — St Louis, Missouri, United States
• North Shore University Hospital-Long Island Jewish Health System — Manhasset, New York, United States
• University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Texas - MD Anderson Cancer Center — Houston, Texas, United States
• University of Utah Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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