Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130715
Status:
COMPLETED
Last Update Posted:
2015-03-12
First Post:
2005-08-15
Brief Title:
Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Prospective Randomized Multicenter Controlled Evaluation of the Efficacy and Safety of Seprafilm in the Reduction of Incidence of Bowel Obstruction in General Surgery
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the efficacy of Seprafilm in reducing the incidence of bowel obstruction and to evaluate the incidence of all serious adverse events SAEs associated with the use of Seprafilm occurring within 30 days postoperatively and the incidence of abdominopelvic abscess within 6 months postoperatively
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None