Study Results
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View full resultsBasic Information
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COMPLETED
NA
83 participants
INTERVENTIONAL
2007-09-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Strattice Reconstructive Tissue Matrix
LTM (Strattice Reconstructive Tissue Matrix)
Surgical mesh
Interventions
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LTM (Strattice Reconstructive Tissue Matrix)
Surgical mesh
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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LifeCell
INDUSTRY
Responsible Party
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Principal Investigators
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Kamal Itani, MD
Role: PRINCIPAL_INVESTIGATOR
Boston VA Healthcare System
Locations
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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
Countries
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References
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Itani KM, Rosen M, Vargo D, Awad SS, Denoto G 3rd, Butler CE; RICH Study Group. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study. Surgery. 2012 Sep;152(3):498-505. doi: 10.1016/j.surg.2012.04.008. Epub 2012 Jul 3.
Rosen MJ, Denoto G, Itani KM, Butler C, Vargo D, Smiell J, Rutan R. Evaluation of surgical outcomes of retro-rectus versus intraperitoneal reinforcement with bio-prosthetic mesh in the repair of contaminated ventral hernias. Hernia. 2013 Feb;17(1):31-5. doi: 10.1007/s10029-012-0909-2. Epub 2012 Mar 14.
Other Identifiers
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LFC2007.02.01
Identifier Type: -
Identifier Source: org_study_id