Evaluation of the Safety of Sepraspray in Open Abdominal Surgery
- Conditions
- Adhesion Prevention (Abdominal)
- Interventions
- Device: Sepraspray
- Registration Number
- NCT00778479
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 155
- Patients 18 years old and over that require open abdominal surgery
- Patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sepraspray Sepraspray Receive Sepraspray
- Primary Outcome Measures
Name Time Method Morbidity 30 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
CHRU de Lille, Hopital Huriez
🇫🇷Lille, France
Chu Hotel Dieu
🇫🇷Clamond, France
Hopital de la Croix Rousse
🇫🇷Lyon, France
University Hospital
🇸🇪Linkoping, Sweden
Hopital Lariboisiere
🇫🇷Paris, France
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Akademiska Sjukhuset
🇸🇪Uppsala, Sweden