Manageability and Safety Assessment of Sepraspray in Abdominal Surgery.

Adhesion Prevention Clinical Trial

— C-MUST  

Official title:

Manageability and Safety Assessment of the SepraSpray Anti-adhesion Barrier in Abdominal Coelioscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813397
• Other study ID #: SSPRAY00608
• Status: Completed
• Phase: N/A
• First received: December 19, 2008
• Last updated: May 21, 2015
• Start date: September 2008
• Est. completion date: July 2009

Study information

• Verified date: May 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesion Prevention
• Tissue Adhesions

Intervention

Device:
• Sepraspray
Max. 10g of Sepraspray

Locations

Country	Name	City	State
France	CHU Amiens Nord	Amiens Cedex 1
France	Hopital Avicenne	Bobingy
France	Hopital Beaujon	Clichy
France	Centre Hospitalier Simone Veil	Eaubonne Cedex
France	Hopital Nord	Marseille cedex 20
France	CHR Nantes-Hopital Hotel Dieu	Nantes Cedex 1
France	CHU Hopital de le'Archet	Nice
France	Institut Mutualiste Montsouris	Paris
France	CHU Bordeaux-Hopital du Haut Leveque	Pessac Cedex
France	CHU Lyon Sud	Pierre Benite
France	Centre Hospitalier Intercommunal de Poissy Saint-German	Poissy
France	CHU Charles Nicolle	Rouen Cedex
France	CHU Bordeaux Saint Andre	Talence Cedex 1
France	Hopital Purpan	Toulouse Cedex 9
France	CHU Hopital Trousseau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity		30 days	No