Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00665730
Recruitment Status : Terminated (Study terminated due to low enrollment.)
First Posted : April 24, 2008
Last Update Posted : May 8, 2015
Information provided by (Responsible Party):
Sanofi ( 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.

Condition or disease Intervention/treatment Phase
Abdominal Adhesions Device: Sepraspray Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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)
Study Start Date : July 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: 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.
Device: Sepraspray
No Intervention: Control
No anti-adhesion treatment used.

Primary Outcome Measures :
  1. Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision [ Time Frame: 8-14 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications. [ Time Frame: 8-14 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00665730

Layout table for location information
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
Layout table for investigator information
Study Director: Medical Monitor Genzyme, a Sanofi Company
Layout table for additonal information
Responsible Party: Genzyme, a Sanofi Company Identifier: NCT00665730    
Other Study ID Numbers: SSPRAY00406
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Tissue Adhesions
Pathologic Processes