Evaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions

Not Applicable

Terminated

• Conditions: Abdominal Adhesions

• Registration Number: NCT00665730
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

This study will examine the safety and efficacy of Sepraspray in the following model of abdominal surgery: total proctocolectomy and pelvic pouch with diverting ileostomy via laparotomy to treat ulcerative colitis or familial polyposis. Adhesion formation will be evaluated laparoscopically at ileostomy take down. NOTE: A decision was made to terminate this study in June 2008 due to low enrollment.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-24
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-07
• Last Update Posted: 2015-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Patients who are scheduled to undergo a total proctocolectomy and a pelvic pouch with diverting ileostomy.

Exclusion Criteria

• Patients who are pregnant.
• Patients with ongoing abdominal abscess.
• Patients with ongoing bacterial peritonitis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision	8-14 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision.	8-14 weeks
Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications.	8-14 weeks