Manageability and Safety Assessment of Sepraspray in Abdominal Surgery.

Not Applicable

Completed

• Conditions: Adhesion Prevention
• Interventions: Device: Sepraspray

• Registration Number: NCT00813397
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-23
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sepraspray	Sepraspray	Receive Sepraspray

Primary Outcome Measures

Name	Time	Method
Morbidity	30 days

Trial Locations

Locations (15)

Hopital Avicenne; 🇫🇷 Bobingy, France

CHU Amiens Nord; 🇫🇷 Amiens Cedex 1, France

CHU Hopital de le'Archet; 🇫🇷 Nice, France

Hopital Beaujon; 🇫🇷 Clichy, France

Centre Hospitalier Simone Veil; 🇫🇷 Eaubonne Cedex, France

CHR Nantes-Hopital Hotel Dieu; 🇫🇷 Nantes Cedex 1, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

CHU Lyon Sud; 🇫🇷 Pierre Benite, France

CHU Bordeaux-Hopital du Haut Leveque; 🇫🇷 Pessac Cedex, France

CHU Charles Nicolle; 🇫🇷 Rouen Cedex, France

Centre Hospitalier Intercommunal de Poissy Saint-German; 🇫🇷 Poissy, France

Hopital Purpan; 🇫🇷 Toulouse Cedex 9, France

CHU Hopital Trousseau; 🇫🇷 Tours, France

CHU Bordeaux Saint Andre; 🇫🇷 Talence Cedex 1, France

Hopital Nord; 🇫🇷 Marseille cedex 20, France