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

May 21, 2015 updated by: Genzyme, a Sanofi Company

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sepraspray
Receive Sepraspray
Device: Sepraspray
Max. 10g of Sepraspray
NO_INTERVENTION: Control
No Treatment, No Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morbidity
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (ESTIMATE)

December 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSPRAY00608

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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