NCT00130715

Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery

A Prospective, Randomized, Multicenter, Controlled Evaluation of the Efficacy and Safety of Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intestinal Obstruction
• Digestive System Surgical Procedures

Interventions

Type	Name	Description
DEVICE	Seprafilm Bioresorbable Membrane

Timeline

• Start date: 1998-06-01
• Completion: 2003-08-01
• First posted: 2005-08-16
• Last updated: 2015-03-12

Locations

21 sites across 5 countries: United States, Canada, Germany, Netherlands, United Kingdom