Evaluation of the Safety of Sepraspray in Open Abdominal Surgery
This study has been terminated.
(Terminated by Sponsor: see details below)
Sponsor:
Genzyme
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00778479
First received: October 22, 2008
Last updated: October 2, 2010
Last verified: October 2010
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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:
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
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
Investigators
| Study Director: | Medical Monitor | Genzyme |
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 June 17, 2013