To evaluate the efficacy of Seprafilm in reducing the incidence of bowel obstruction and to evaluate the incidence of all SAEs associated with the use of Seprafilm occuring within 30 days postoperatively, and the incidence of abdominopelvic abscess within 6 months postoperatively

Condition	Intervention
Patients undergoing a variety of abdominal surgical procedures	Device: Seprafilm Bioresorbable Membrane

Further Study Details: 

Primary Outcomes: Reducing the incidence of bowel obstruction following intestinal resection, and subsequently, reducing the number of re-operations.

Ages Eligible for Study:  18 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

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

Arizona
      Mayo Clinic, Scottsdale,  Arizona,  United States
California
      Kaiser Permanente Medical Center, Los Angeles,  California,  United States
      USC School of Medicine, Los Angeles,  California,  United States
      Harbor UCLA, Torrence,  California,  United States
District of Columbia
      Washington Hospital Center, Washington,  District of Columbia,  United States
Florida
      Cleveland Clinic, Weston,  Florida,  United States
Maryland
      Johns Hopkins Medical Center, Baltimore,  Maryland,  United States
Massachusetts
      Boston Medical Center, Boston,  Massachusetts,  United States
      Brigham and Women''''s Hospital, Boston,  Massachusetts,  United States
Minnesota
      Colon & Rectal Surgery Associates, St. Paul,  Minnesota,  United States
      Mayo Medical Center, Rochester,  Minnesota,  United States
Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  United States
New York
      Mount Sinai School of Medicine, New York,  New York,  United States
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  United States
Ohio
      Cleveland Clinic, Cleveland,  Ohio,  United States
Texas
      University of Texas Medical School, Houston,  Texas,  United States
Canada, Ontario
      Mount Sinai Hospital, Toronto,  Ontario,  Canada
Germany
      University of Erlangen, Erlangen,  Germany
Netherlands
      University Hospital Nijmegen, Nijmegan,  Netherlands
United Kingdom
      St. Mary''''s Hospital, London,  United Kingdom
      University of Hull, Hull,  United Kingdom

Study ID Numbers:  SF97-0601
Last Updated:  August 15, 2005
Record first received:  August 15, 2005
ClinicalTrials.gov Identifier:  NCT00130715
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23