NCT00778479TerminatedNot Applicable
Evaluation of the Safety of Sepraspray in Open Abdominal Surgery
Genzyme, a Sanofi Company7 sites in 2 countries155 target enrollmentStarted: October 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 155
- Locations
- 7
- Primary Endpoint
- Morbidity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Morbidity
Time Frame: 30 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (7)
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