Back to resultsEvaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions
Primary Purpose
Abdominal Adhesions
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sepraspray
Sponsored by
About this trial
This is an interventional prevention trial for Abdominal Adhesions
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sepraspray
Control
Arm Description
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 anti-adhesion treatment used.
Outcomes
Primary Outcome Measures
Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision
Secondary Outcome Measures
Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision.
Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00665730
Brief Title
Evaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions
Official Title
Evaluation of the Safety and Effectiveness of Sepraspray™ in Limiting the Formation of Postoperative Adhesions to Serosal Tissue (Abdominal Surgery)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to low enrollment.
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Adhesions
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sepraspray
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No anti-adhesion treatment used.
Intervention Type
Device
Intervention Name(s)
Sepraspray
Primary Outcome Measure Information:
Title
Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision
Time Frame
8-14 weeks
Secondary Outcome Measure Information:
Title
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
Title
Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications.
Time Frame
8-14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Masarykova
Country
Czech Republic
City
Praha
Country
Czech Republic
City
Aarhus C
Country
Denmark
City
Lille Cedex
Country
France
City
Heidelberg
Country
Germany
City
Cottingham
State/Province
East Yorkshire
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions
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