Antiseptic Use and Dressing Application | NCT00389558

Studies
Antiseptic Use and Dressing Application

NCT00389558

Sponsor

Maternite Regionale Universitaire

Status

Completed

Last Update Posted

Sep 21, 2009Estimated

Enrollment

453Actual

Phase

Phase 4

Conditions

Skin Colonization
Catheterization
Bacterial Infection

Interventions

disinfection efficacy using Biseptine
disinfection efficacy using Amukin

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Sep 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Oct 17, 2006

First Submission Date that Met QC Criteria

Oct 17, 2006

First Posted Date

Oct 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2009

Last Update Posted Date

Sep 21, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purposes of the study are:

To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used for the disinfection of the dressing application for an epicutaneocavous catheter (EPI).
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

453Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Active Comparator	Biseptine	Procedure: disinfection efficacy using Biseptine
1	Active Comparator	Amukin	Procedure: disinfection efficacy using Amukin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
disinfection efficacy using Biseptine	Procedure	Detersion and antiseptic application when changing catheter dressing	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy on skin colonization of two commercially available antiseptics		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
In case of nosocomial infection, relationship with skin bacteria		2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All infants admitted to the Neonatal Intensive Care Unit
Epicutaneocavous catheter insertion indication

Exclusion Criteria:

Epicutaneocavous catheter not inserted within the Unit

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Michel HASCOET, MD	University of NANCY, France	Study Director
Monique LUX, Pharmacist	Maternite Regionale Universitaire	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maternite Regionale Universitaire		Nancy		54042	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11519913	Background	Mahieu LM, De Dooy JJ, De Muynck AO, Van Melckebeke G, Ieven MM, Van Reempts PJ. Microbiology and risk factors for catheter exit-site and -hub colonization in neonatal intensive care unit patients. Infect Control Hosp Epidemiol. 2001 Jun;22(6):357-62. doi: 10.1086/501913.

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D007612	Kanamycin
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates