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, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00665730
First received: April 23, 2008
Last updated: October 2, 2010
Last verified: October 2010
  Purpose

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Czech Republic
Masarykova, Czech Republic
Praha, Czech Republic
Denmark
Aarhus C, Denmark
France
Lille Cedex, France
Germany
Heidelberg, Germany
United Kingdom
Cottingham, East Yorkshire, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014