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Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

Primary Purpose

Adhesion Prevention (Abdominal)

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sepraspray
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesion Prevention (Abdominal)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients 18 years old and over that require open abdominal surgery

Exclusion Criteria:

  • Patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy

Sites / Locations

  • Chu Hotel Dieu
  • CHRU de Lille, Hopital Huriez
  • Hopital de la Croix Rousse
  • Hopital Lariboisiere
  • University Hospital
  • Karolinska University Hospital
  • Akademiska Sjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sepraspray

Control

Arm Description

Receive Sepraspray

no treatment

Outcomes

Primary Outcome Measures

Morbidity

Secondary Outcome Measures

Full Information

First Posted
October 22, 2008
Last Updated
March 19, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00778479
Brief Title
Evaluation of the Safety of Sepraspray in Open Abdominal Surgery
Official Title
Evaluation of the Safety of Sepraspray in Open Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Terminated by Sponsor: see details below
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (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 Performance of Sepraspray in Patients undergoing open abdominal surgery NOTE regarding reason for study termination: A patient death reported during the trial warranted temporary suspension for review by the independent data review committee. Although the committee recommended continuing enrollment, enrollment was electively terminated by the sponsor. A preliminary analysis did not identify any new risk that was not listed on the investigational labeling for this product. A full analysis of the results is expected to allow characterization of the risk/benefit and clinical utility of the product in the exposed patient population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesion Prevention (Abdominal)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sepraspray
Arm Type
Experimental
Arm Description
Receive Sepraspray
Arm Title
Control
Arm Type
No Intervention
Arm Description
no treatment
Intervention Type
Device
Intervention Name(s)
Sepraspray
Intervention Description
Max. 10g of Sepraspray
Primary Outcome Measure Information:
Title
Morbidity
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18 years old and over that require open abdominal surgery Exclusion Criteria: Patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy
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:
Facility Name
Chu Hotel Dieu
City
Clamond
Country
France
Facility Name
CHRU de Lille, Hopital Huriez
City
Lille
Country
France
Facility Name
Hopital de la Croix Rousse
City
Lyon
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
Country
France
Facility Name
University Hospital
City
Linkoping
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

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