Clinical Trial: Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Randomized, Multicenter, Controlled Evaluation of the Efficacy and Safety of Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery
Brief Summary: 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.
Detailed Summary:
Sponsor: Genzyme, a Sanofi Company
Current Primary Outcome: Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations
Original Primary Outcome: Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sanofi
Dates:
Date Received: August 15, 2005
Date Started: June 1998
Date Completion: August 2003
Last Updated: March 11, 2015
Last Verified: March 2015