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Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT00778479
Recruitment Status : Terminated (Terminated by Sponsor: see details below)
First Posted : October 23, 2008
Last Update Posted : March 24, 2015
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:

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 or disease Intervention/treatment
Adhesion Prevention (Abdominal) Device: Sepraspray

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety of Sepraspray in Open Abdominal Surgery
Study Start Date : October 2008
Primary Completion Date : May 2009
Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: Sepraspray
Receive Sepraspray
Device: Sepraspray
Max. 10g of Sepraspray
No Intervention: Control
no treatment

Primary Outcome Measures :
  1. Morbidity [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00778479

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

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00778479     History of Changes
Other Study ID Numbers: SSPRAY00508
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015