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

This study has been completed.
Sponsor:
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00813397
First received: December 19, 2008
Last updated: October 2, 2010
Last verified: October 2010
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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
U.S. FDA Resources

Further study details as provided by Genzyme:

Primary Outcome Measures:
  • Morbidity [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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
 Other: No Intervention
No Intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Director: Medical Monitor Genzyme
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00813397     History of Changes
Other Study ID Numbers: SSPRAY00608
Study First Received: December 19, 2008
Last Updated: October 2, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013