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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00813397
First Posted: December 23, 2008
Last Update Posted: May 22, 2015
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.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
  Purpose
This study will examine the performance of SeprasSpray in patients undergoing abdominal surgery (laparoscopic).

Condition Intervention
Adhesion Prevention Device: Sepraspray

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Manageability and Safety Assessment of the SepraSpray Anti-adhesion Barrier in Abdominal Coelioscopic Surgery

Resource links provided by NLM:


Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:
  • Morbidity [ Time Frame: 30 days ]

Enrollment: 210
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sepraspray
Receive Sepraspray
Device: Sepraspray
Max. 10g of Sepraspray
No Intervention: Control
No Treatment, No Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00813397


Locations
France
CHU Amiens Nord
Amiens Cedex 1, France, 80054
Hopital Avicenne
Bobingy, France, 93009
Hopital Beaujon
Clichy, France, 92110
Centre Hospitalier Simone Veil
Eaubonne Cedex, France, 95602
Hopital Nord
Marseille cedex 20, France, 13915
CHR Nantes-Hopital Hotel Dieu
Nantes Cedex 1, France, 44093
CHU Hopital de le'Archet
Nice, France, 06200
Institut Mutualiste Montsouris
Paris, France, 75014
CHU Bordeaux-Hopital du Haut Leveque
Pessac Cedex, France, 33604
CHU Lyon Sud
Pierre Benite, France, 69495
Centre Hospitalier Intercommunal de Poissy Saint-German
Poissy, France, 78300
CHU Charles Nicolle
Rouen Cedex, France, 76031
CHU Bordeaux Saint Andre
Talence Cedex 1, France, 33404
Hopital Purpan
Toulouse Cedex 9, France, 31509
CHU Hopital Trousseau
Tours, France, 37044
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00813397     History of Changes
Other Study ID Numbers: SSPRAY00608
First Submitted: December 19, 2008
First Posted: December 23, 2008
Last Update Posted: May 22, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes