Antiseptic Use and Dressing Application - Full Text View

Sponsored by:	Maternite Regionale Universitaire
Information provided by:	Maternite Regionale Universitaire
ClinicalTrials.gov Identifier:	NCT00389558

Purpose

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	Intervention	Phase
Skin Colonization Catheterization Bacterial Infection	Procedure: disinfection efficacy using Biseptine Procedure: disinfection efficacy using Amukin	Phase IV

MedlinePlus related topics: Bacterial Infections

Drug Information available for: Amikacin Amikacin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention

Further study details as provided by Maternite Regionale Universitaire:

Primary Outcome Measures:

Efficacy on skin colonization of two commercially available antiseptics [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

In case of nosocomial infection, relationship with skin bacteria [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment:	453
Study Start Date:	September 2006
Study Completion Date:	October 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator Biseptine	Procedure: disinfection efficacy using Biseptine Detersion and antiseptic application when changing catheter dressing
1: Active Comparator Amukin	Procedure: disinfection efficacy using Amukin Detersion and antiseptic application when changing catheter dressing

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.

Eligibility

Ages Eligible for Study:	up to 3 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389558

Locations

France
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

More Information

(home page of the hospital) This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Maternite Regionale Universitaire ( Prof JM HASCOET )
Study ID Numbers:	MRAP190406
Study First Received:	October 17, 2006
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00389558
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Maternite Regionale Universitaire:

Skin colonization
Antiseptic
Epicutaneocavous catheter dressing
Infant

Study placed in the following topic categories:

Bacterial Infections
Amikacin

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases

Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009