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Antiseptic Use and Dressing Application

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00389558
Enrollment
453
Registered
2006-10-19
Start date
2006-09-30
Completion date
2008-10-31
Last updated
2009-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infection, Catheterization, Skin Colonization

Keywords

Skin colonization, Antiseptic, Epicutaneocavous catheter dressing, Infant

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.

Interventions

PROCEDUREdisinfection efficacy using Biseptine

Detersion and antiseptic application when changing catheter dressing

PROCEDUREdisinfection efficacy using Amukin

Detersion and antiseptic application when changing catheter dressing

Sponsors

Maternite Regionale Universitaire
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Epicutaneocavous catheter not inserted within the Unit

Design outcomes

Primary

MeasureTime frame
Efficacy on skin colonization of two commercially available antiseptics2 weeks

Secondary

MeasureTime frame
In case of nosocomial infection, relationship with skin bacteria2 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026