Antiseptic Use and Dressing Application

Sponsor

Maternite Regionale Universitaire (Other)

Overall Status

Completed

CT.gov ID

NCT00389558

Collaborator

(none)

453

Enrollment

Location

Arms

Duration (Months)

18.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Colonization Catheterization Bacterial Infection	Procedure: disinfection efficacy using Biseptine Procedure: disinfection efficacy using Amukin	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

453 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2 Biseptine	Procedure: disinfection efficacy using Biseptine Detersion and antiseptic application when changing catheter dressing Other Names: Biseptine
Active Comparator: 1 Amukin	Procedure: disinfection efficacy using Amukin Detersion and antiseptic application when changing catheter dressing Other Names: Amukin

Arm

Intervention/Treatment

Active Comparator: 2

Biseptine

Procedure: disinfection efficacy using Biseptine

Detersion and antiseptic application when changing catheter dressing

Other Names:

Biseptine

Active Comparator: 1

Amukin

Procedure: disinfection efficacy using Amukin

Detersion and antiseptic application when changing catheter dressing

Other Names:

Amukin

Outcome Measures

Primary Outcome Measures

Efficacy on skin colonization of two commercially available antiseptics [2 weeks]

Secondary Outcome Measures

In case of nosocomial infection, relationship with skin bacteria [2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 3 Months

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maternite Regionale Universitaire	Nancy		France	54042

Sponsors and Collaborators

Maternite Regionale Universitaire

Investigators

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