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Manageability and Safety Assessment of Sepraspray in Abdominal Surgery. (C-MUST)

Primary Purpose

Adhesion Prevention

Status
Completed
Phase
Not Applicable
Locations
France
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

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who are pregnant or have an ongoing infectious complications from a previous surgery

Sites / Locations

  • CHU Amiens Nord
  • Hopital Avicenne
  • Hopital Beaujon
  • Centre Hospitalier Simone Veil
  • Hopital Nord
  • CHR Nantes-Hopital Hotel Dieu
  • CHU Hopital de le'Archet
  • Institut Mutualiste Montsouris
  • CHU Bordeaux-Hopital du Haut Leveque
  • CHU Lyon Sud
  • Centre Hospitalier Intercommunal de Poissy Saint-German
  • CHU Charles Nicolle
  • CHU Bordeaux Saint Andre
  • Hopital Purpan
  • CHU Hopital Trousseau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sepraspray

Control

Arm Description

Receive Sepraspray

No Treatment, No Placebo

Outcomes

Primary Outcome Measures

Morbidity

Secondary Outcome Measures

Full Information

First Posted
December 19, 2008
Last Updated
May 21, 2015
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00813397
Brief Title
Manageability and Safety Assessment of Sepraspray in Abdominal Surgery.
Acronym
C-MUST
Official Title
Manageability and Safety Assessment of the SepraSpray Anti-adhesion Barrier in Abdominal Coelioscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 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 SeprasSpray in patients undergoing abdominal surgery (laparoscopic).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
210 (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, No Placebo
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 laparoscopic abdominal surgery Exclusion Criteria: Patients who are pregnant or have an ongoing infectious complications from a previous surgery
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 Amiens Nord
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Hopital Avicenne
City
Bobingy
ZIP/Postal Code
93009
Country
France
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Centre Hospitalier Simone Veil
City
Eaubonne Cedex
ZIP/Postal Code
95602
Country
France
Facility Name
Hopital Nord
City
Marseille cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
CHR Nantes-Hopital Hotel Dieu
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
CHU Hopital de le'Archet
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU Bordeaux-Hopital du Haut Leveque
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Intercommunal de Poissy Saint-German
City
Poissy
ZIP/Postal Code
78300
Country
France
Facility Name
CHU Charles Nicolle
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
CHU Bordeaux Saint Andre
City
Talence Cedex 1
ZIP/Postal Code
33404
Country
France
Facility Name
Hopital Purpan
City
Toulouse Cedex 9
ZIP/Postal Code
31509
Country
France
Facility Name
CHU Hopital Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25348087
Citation
Berdah SV, Mariette C, Denet C, Panis Y, Laurent C, Cotte E, Huten N, Le Peillet Feuillet E, Duron JJ. A multicentre, randomised, controlled trial to assess the safety, ease of use, and reliability of hyaluronic acid/carboxymethylcellulose powder adhesion barrier versus no barrier in colorectal laparoscopic surgery. Trials. 2014 Oct 27;15:413. doi: 10.1186/1745-6215-15-413.
Results Reference
derived

Learn more about this trial

Manageability and Safety Assessment of Sepraspray in Abdominal Surgery.

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