Evaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Evaluation of the Safety and Effectiveness of Sepraspray™ in Limiting the Formation of Postoperative Adhesions to Serosal Tissue (Abdominal Surgery)|
- Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision [ Time Frame: 8-14 weeks ] [ Designated as safety issue: No ]
- Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision. [ Time Frame: 8-14 weeks ] [ Designated as safety issue: No ]
- Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications. [ Time Frame: 8-14 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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.
No Intervention: Control
No anti-adhesion treatment used.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665730
|Masarykova, Czech Republic|
|Praha, Czech Republic|
|Aarhus C, Denmark|
|Lille Cedex, France|
|Cottingham, East Yorkshire, United Kingdom|
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|