Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482547
Status:
TERMINATED
Last Update Posted:
2017-02-28
First Post:
2007-06-04
Brief Title:
Study of a Urethral Catheter Coated With Eluting Silver Salts SUCCESS
Sponsor:
C R Bard
Organization:
C R Bard
Study Overview
Official Title:
Study of a Urethral Catheter Coated With Eluting Silver Salts
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated for futility reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUCCESS
Brief Summary:
Urinary catheters are often needed in hospital patients but their use can increase the chance that a catheter associated urinary tract infection called a CAUTI may occur This study will try to determine if patients who get a new silver coated catheter will have slower to time to development of a CAUTI compared to patients who get an uncoated catheter
Detailed Description:
This study is a prospective multicenter randomized controlled pivotal study designed to compare the time to occurrence and incidence of CAUTI in subjects catheterized with a new hydrogel-silver salts latex catheter test to those of subjects catheterized with a silicone elastomer-coated latex catheter control
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