Antiseptic Use and Dressing Application

Phase 4

Completed

• Conditions: Skin Colonization; Catheterization; Bacterial Infection

• Registration Number: NCT00389558
• Lead Sponsor: Maternite Regionale Universitaire

Brief 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.

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-17
• Study First Submitted QC: 2006-10-17
• Study First Posted: 2006-10-19
• Primary Completion: 2008-09
• Study Completion: 2008-10
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-18
• Last Update Posted: 2009-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 453

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy on skin colonization of two commercially available antiseptics	2 weeks

Secondary Outcome Measures

Name	Time	Method
In case of nosocomial infection, relationship with skin bacteria	2 weeks

Trial Locations

Locations (1)

Maternite Regionale Universitaire; 🇫🇷 Nancy, France