Manageability and Safety Assessment of Sepraspray in Abdominal Surgery. - Full Text View

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

This study has been completed.

First Received: December 19, 2008 Last Updated: July 29, 2009 History of Changes

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00813397

Purpose

This study will examine the performance of SeprasSpray in patients undergoing abdominal surgery (laparoscopic).

Condition	Intervention
Adhesion Prevention	Device: Sepraspray Other: No Intervention

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety Study
Official Title:	Manageability and Safety Assessment of the SepraSpray Anti-adhesion Barrier in Abdominal Coelioscopic Surgery

Resource links provided by NLM:

MedlinePlus related topics: Adhesions Surgery

Further study details as provided by Genzyme:

Primary Outcome Measures:

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
Sepraspray: Experimental Receive Sepraspray	Device: Sepraspray Max. 10g of Sepraspray
Control: No Intervention No Treatment, No Placebo	Other: No Intervention No Intervention

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813397

Locations

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

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

No publications provided

Responsible Party:	Genzyme Corporation ( Medical Monitor )
Study ID Numbers:	SSPRAY00608
Study First Received:	December 19, 2008
Last Updated:	July 29, 2009
ClinicalTrials.gov Identifier:	NCT00813397 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Adhesions

Additional relevant MeSH terms:

Pathologic Processes
Adhesions

ClinicalTrials.gov processed this record on August 28, 2009