Evaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions
Not Applicable
Terminated
- Conditions
- Abdominal Adhesions
- Interventions
- Device: Sepraspray
- 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
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
- Arm && Interventions
Group Intervention Description Sepraspray Sepraspray Sepraspray Powder applied on the viscera directly under the midline incision followed by incision closure. Sepraspray dose applied was between 2 g and 4 g per patient.
- 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