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

This study has been terminated.
(Study terminated due to low enrollment.)
Sponsor:
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00665730
First received: April 23, 2008
Last updated: October 2, 2010
Last verified: October 2010
History of Changes

April 23, 2008
October 2, 2010
July 2007
June 2008   (final data collection date for primary outcome measure)
Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision [ Time Frame: 8-14 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00665730 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions
Evaluation of the Safety and Effectiveness of Sepraspray™ in Limiting the Formation of Postoperative Adhesions to Serosal Tissue (Abdominal Surgery)

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Abdominal Adhesions
Device: Sepraspray
  • Experimental: 1
    Intervention: Device: Sepraspray
  • No Intervention: 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
75
June 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Denmark,   France,   Germany,   United Kingdom
 
NCT00665730
SSPRAY00406
Yes
Medical Monitor, Genzyme Corporation
Genzyme
Not Provided
Study Director: Medical Monitor Genzyme
Genzyme
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP