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Antiseptic Use and Dressing Application

Primary Purpose

Skin Colonization, Catheterization, Bacterial Infection

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

disinfection efficacy using Biseptine

disinfection efficacy using Amukin

About this trial

This is an interventional prevention trial for Skin Colonization focused on measuring Skin colonization, Antiseptic, Epicutaneocavous catheter dressing, Infant

Eligibility Criteria

undefined - 3 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Epicutaneocavous catheter not inserted within the Unit

Sites / Locations

Maternite Regionale Universitaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Biseptine

Amukin

Outcomes

Primary Outcome Measures

Efficacy on skin colonization of two commercially available antiseptics

Secondary Outcome Measures

In case of nosocomial infection, relationship with skin bacteria

Full Information

NCT ID

NCT00389558

First Posted

October 17, 2006

Last Updated

September 18, 2009

Sponsor

Maternite Regionale Universitaire

1. Study Identification

Unique Protocol Identification Number

NCT00389558

Brief Title

Antiseptic Use and Dressing Application

Official Title

Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Maternite Regionale Universitaire

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Colonization, Catheterization, Bacterial Infection

Keywords

Skin colonization, Antiseptic, Epicutaneocavous catheter dressing, Infant

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

453 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Biseptine

Arm Title

Arm Type

Active Comparator

Arm Description

Amukin

Intervention Type

Procedure

Intervention Name(s)

disinfection efficacy using Biseptine

Other Intervention Name(s)

Biseptine

Intervention Description

Detersion and antiseptic application when changing catheter dressing

Intervention Type

Procedure

Intervention Name(s)

disinfection efficacy using Amukin

Other Intervention Name(s)

Amukin

Intervention Description

Detersion and antiseptic application when changing catheter dressing

Primary Outcome Measure Information:

Title

Efficacy on skin colonization of two commercially available antiseptics

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

In case of nosocomial infection, relationship with skin bacteria

Time Frame

2 weeks

10. Eligibility

Sex

All

Maximum Age & Unit of Time

3 Months

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Michel HASCOET, MD

Organizational Affiliation

University of NANCY, France

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Monique LUX, Pharmacist

Organizational Affiliation

Maternite Regionale Universitaire

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maternite Regionale Universitaire

City

Nancy

ZIP/Postal Code

54042

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

11519913

Citation

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.

Results Reference

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Antiseptic Use and Dressing Application

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