Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT00389558
Status:
COMPLETED
Last Update Posted:
2009-09-21
First Post:
2006-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antiseptic Use and Dressing Application
Sponsor:
Maternite Regionale Universitaire
Organization:
Study Overview
Official Title:
Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of the study are:
1. To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used for the disinfection of the dressing application for an epicutaneocavous catheter (EPI).
2. To evaluate whether the bacteria responsible for nosocomial infection is comparable to the flora diagnosed at the EPI site.
1. To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used for the disinfection of the dressing application for an epicutaneocavous catheter (EPI).
2. To evaluate whether the bacteria responsible for nosocomial infection is comparable to the flora diagnosed at the EPI site.
Detailed Description:
Epicutaneocavous catheter is a significant risk factor for nosocomial infection in newborn infants. These infections have been related to local bacterial colonisation. Therefore thorough disinfection should lower the risk of nosocomial infection. However, the local efficacy of antiseptic use has not yet been clearly evaluated in this situation.
Study Oversight
Has Oversight DMC:
False
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?: