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NCT00389558 Clinical Trial

Antiseptic Use and Dressing Application

Bacterial Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00389558
Other study ID # MRAP190406
Secondary ID
Status Completed
Phase Phase 4
First received October 17, 2006
Last updated September 18, 2009
Start date September 2006
Est. completion date October 2008

Study information
Verified date September 2009
Source Maternite Regionale Universitaire
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 453
Est. completion date October 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group N/A to 3 Months
Eligibility Inclusion Criteria:

- All infants admitted to the Neonatal Intensive Care Unit

- Epicutaneocavous catheter insertion indication

Exclusion Criteria:

- Epicutaneocavous catheter not inserted within the Unit

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• disinfection efficacy using Biseptine
Detersion and antiseptic application when changing catheter dressing
• disinfection efficacy using Amukin
Detersion and antiseptic application when changing catheter dressing

Locations
Country Name City State
France Maternite Regionale Universitaire Nancy

Sponsors (1)
Lead Sponsor Collaborator
Maternite Regionale Universitaire

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy on skin colonization of two commercially available antiseptics 2 weeks No
Secondary In case of nosocomial infection, relationship with skin bacteria 2 weeks No
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