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A Prospective, Randomized, Multicenter, Controlled Evaluation of the Efficacy and Safety of Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery
The purpose of the study is to evaluate the efficacy of Seprafilm in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events (SAEs) associated with the use of Seprafilm occurring within 30 days postoperatively, and the incidence of abdominopelvic abscess within 6 months postoperatively.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic
Scottsdale, Arizona, United States
Kaiser Permanente Medical Center
Los Angeles, California, United States
USC School of Medicine
Los Angeles, California, United States
Harbor UCLA
Torrence, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Cleveland Clinic
Weston, Florida, United States
Johns Hopkins Medical Center
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Medical Center
Rochester, Minnesota, United States
Start Date
June 1, 1998
Completion Date
August 1, 2003
Last Updated
March 12, 2015
Seprafilm Bioresorbable Membrane
DEVICE
Lead Sponsor
Genzyme, a Sanofi Company
NCT06901544
NCT04791566
Data Source & Attribution
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