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

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

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.

Condition Intervention
Abdominal Adhesions
Device: Sepraspray

Study Type: Interventional
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)

Resource links provided by NLM:

Further study details as provided by Genzyme, a Sanofi Company:

Primary Outcome Measures:
  • Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision [ Time Frame: 8-14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 75
Study Start Date: July 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: Sepraspray
No Intervention: 2


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665730

Czech Republic
Masarykova, Czech Republic
Praha, Czech Republic
Aarhus C, Denmark
Lille Cedex, France
Heidelberg, Germany
United Kingdom
Cottingham, East Yorkshire, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00665730     History of Changes
Other Study ID Numbers: SSPRAY00406
Study First Received: April 23, 2008
Last Updated: October 2, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Denmark: Danish Medicines Agency
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Tissue Adhesions
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014