Antiseptic Use and Dressing Application

NCT ID: NCT00389558

Last Updated: 2009-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

453 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Skin Colonization Catheterization Bacterial Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2

Biseptine

Group Type ACTIVE_COMPARATOR

disinfection efficacy using Biseptine

Intervention Type PROCEDURE

Detersion and antiseptic application when changing catheter dressing

1

Amukin

Group Type ACTIVE_COMPARATOR

disinfection efficacy using Amukin

Intervention Type PROCEDURE

Detersion and antiseptic application when changing catheter dressing

Interventions

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disinfection efficacy using Biseptine

Detersion and antiseptic application when changing catheter dressing

Intervention Type PROCEDURE

disinfection efficacy using Amukin

Detersion and antiseptic application when changing catheter dressing

Intervention Type PROCEDURE

Other Intervention Names

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Biseptine Amukin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Epicutaneocavous catheter not inserted within the Unit
Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maternite Regionale Universitaire

OTHER

Sponsor Role lead

Responsible Party

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Maternite Regionale Universitaire

Principal Investigators

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Jean-Michel HASCOET, MD

Role: STUDY_DIRECTOR

University of NANCY, France

Monique LUX, Pharmacist

Role: PRINCIPAL_INVESTIGATOR

Maternite Regionale Universitaire

Locations

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Maternite Regionale Universitaire

Nancy, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 11519913 (View on PubMed)

Other Identifiers

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MRAP190406

Identifier Type: -

Identifier Source: org_study_id

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