Evaluation of the Safety of Sepraspray in Open Abdominal Surgery
NCT ID: NCT00778479
Last Updated: 2015-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
155 participants
INTERVENTIONAL
2008-10-31
2009-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sepraspray
Receive Sepraspray
Sepraspray
Max. 10g of Sepraspray
Control
no treatment
No interventions assigned to this group
Interventions
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Sepraspray
Max. 10g of Sepraspray
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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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
Linköping, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Countries
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Other Identifiers
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SSPRAY00508
Identifier Type: -
Identifier Source: org_study_id
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