Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2008-12-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Strattice fascial inlay
Strattice will be placed as a fascial inlay to support the ostomy site
Strattice Reconstructive Matrix
Strattice will be placed as a fascial inlay to support stoma sites
Standard ostomy construction
Ostomy will be created in the standard fashion
Standard ostomy creation
Ostomy will be created as routinely performed
Interventions
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Strattice Reconstructive Matrix
Strattice will be placed as a fascial inlay to support stoma sites
Standard ostomy creation
Ostomy will be created as routinely performed
Eligibility Criteria
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Inclusion Criteria
* need for permanent ileostomy or colostomy
Exclusion Criteria
* has previously implanted surgical mesh at site of planned ostomy
* requires a temporary ostomy
* has need for multiple ostomies
* is receiving chronic immunosuppression therapy, has MELD score of \> 17, has severe COPD, systemic infection, or known collagen disorder
* is bedridden or otherwise non-ambulatory
18 Years
ALL
No
Sponsors
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LifeCell
INDUSTRY
Responsible Party
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Principal Investigators
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James Fleshman, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University, St Louis MO
Locations
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University of South Alabama
Mobile, Alabama, United States
Office of Dr Phillip Fleshner
Los Angeles, California, United States
University of California at Irvine
Orange, California, United States
Stanford University Medical Center
Stanford, California, United States
University of South Florida
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
University of Illinois
Chicago, Illinois, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Louisiana State University
New Orleans, Louisiana, United States
Ochsner Clinic
New Orleans, Louisiana, United States
University of Maryland/Baltimore VA
Baltimore, Maryland, United States
Spectrum Health - Butterworth Hospital
Grand Rapids, Michigan, United States
Colon and Rectal Surgery Associates Ltd
Saint Paul, Minnesota, United States
Washington University School of Medicine - Barnes Jewish West
St Louis, Missouri, United States
Colon & Rectal Surgery Inc
Omaha, Nebraska, United States
Albany Medical College
Albany, New York, United States
Mt Sinai Medical Center
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Christ Hospital Research
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Methodist Hospital
Houston, Texas, United States
University of Vermont
Burlington, Vermont, United States
Countries
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References
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Fleshman JW, Beck DE, Hyman N, Wexner SD, Bauer J, George V; PRISM Study Group. A prospective, multicenter, randomized, controlled study of non-cross-linked porcine acellular dermal matrix fascial sublay for parastomal reinforcement in patients undergoing surgery for permanent abdominal wall ostomies. Dis Colon Rectum. 2014 May;57(5):623-31. doi: 10.1097/DCR.0000000000000106.
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.
Other Identifiers
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LFC2008.01.01
Identifier Type: -
Identifier Source: org_study_id
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