Parastomal Reinforcement With Strattice

Completed · Phase 4

Conditions studied: Parastomal Hernia

In brief

The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.

Key facts

Study ID

NCT00771407

Run by

LifeCell

People needed

120

Starts

2008-12-01

Expected to finish

2012-07-01

Last updated by the study team

2015-09-28

Who can join

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

You may qualify if…

• adults
• need for permanent ileostomy or colostomy

You may not qualify if…

• history of hernia at new ostomy site
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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