Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

This study has been terminated.
(Terminated by Sponsor: see details below)
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00778479
First received: October 22, 2008
Last updated: October 2, 2010
Last verified: October 2010
  Purpose

This study will examine the Performance of Sepraspray in Patients undergoing open abdominal surgery

NOTE regarding reason for study termination:

A patient death reported during the trial warranted temporary suspension for review by the independent data review committee. Although the committee recommended continuing enrollment, enrollment was electively terminated by the sponsor.

A preliminary analysis did not identify any new risk that was not listed on the investigational labeling for this product. A full analysis of the results is expected to allow characterization of the risk/benefit and clinical utility of the product in the exposed patient population.


Condition Intervention
Adhesion Prevention (Abdominal)
Device: Sepraspray

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

Further study details as provided by Genzyme, a Sanofi Company:

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

Enrollment: 155
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: May 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

  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 open abdominal surgery

Exclusion Criteria:

  • Patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778479

Locations
France
Chu Hotel Dieu
Clamond, France
CHRU de Lille, Hopital Huriez
Lille, France
Hopital de la Croix Rousse
Lyon, France
Hopital Lariboisiere
Paris, France
Sweden
University Hospital
Linkoping, Sweden
Karolinska University Hospital
Stockholm, Sweden
Akademiska Sjukhuset
Uppsala, Sweden
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00778479     History of Changes
Other Study ID Numbers: SSPRAY00508
Study First Received: October 22, 2008
Last Updated: October 2, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Sweden: Medical Products Agency

ClinicalTrials.gov processed this record on August 20, 2014