Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions

Inclusion Criteria:

• Written informed consent obtained from the subject or the subject's legally authorized representative prior to study entry
• Male or female subjects > 18 years of age
• Subjects undergoing abdominal surgery with the possibility that a rectal stump would remain due to one or more of the following reasons: inflammatory bowel diseases, neoplasm, colon diverticulitis, colonic obstruction, colon polyposis, peritoneal trauma, fistula, incontinence, or other reasons
• Subjects for whom a second abdominal surgery is planned within approximately eight months of the first surgical procedure.

Exclusion Criteria:

Pre operative:

• Pregnancy and lactation period
• Subjects concurrently participating in another clinical trial with a drug or a device
• Subjects who have participated in a clinical trial with a drug or a device within 30 days prior to this study
• Subjects who have had abdominal/pelvic surgery within six months prior to this study
• Subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation

Intra operative:

• Subjects with peritonitis
• Subjects with gastrointestinal metastatic cancer, or cancer growing per continuitatem into surrounding tissues
• Subjects treated with hemostatic agents (e.g. fibrin sealant, collagen, oxidized cellulose) during the first surgery
• Subjects treated with adhesion prevention agents other than the Anti-Adhesion Product (AAP) (e.g. Intergel® Adhesion Prevention Solution, Seprafilm® Membrane) during the first surgery
• Subjects with major fecal contamination needing an abdominal lavage during the first surgery