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

Genzyme

Status

Completed

Conditions

Digestive System Surgical Procedures

Intestinal Obstruction

Treatments

Device: Seprafilm Bioresorbable Membrane

Study type

Interventional

Funder types

Industry

Identifiers

NCT00130715

SF97-0601

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who were undergoing colon and/or rectal resections and/or adhesiolysis for treatment of bowel obstruction

Exclusion criteria

Patients with any medical condition or disease where 5-year survival was not expected
Patients undergoing laparoscopy
Patients undergoing surgery for treatment of acute abdominal trauma
Patients with an abscess (abdominal or pelvic) present during the initial surgery
Patients with a history of pulmonary embolus or deep vein thrombosis (DVT) within 1 year of surgery