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OpenTrials
Completed

NCT Number: NCT00389558

Antiseptic Use and Dressing Application

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.

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Key information

Conditions

Skin Colonization Bacterial Infection Bacterial Infections Bacterial Infections and Mycoses Catheterization Infections

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maternite Regionale Universitaire

Nancy, 54042, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Epicutaneocavous catheter not inserted within the Unit

Treatment and study plan

disinfection efficacy using Biseptine

Procedure

Detersion and antiseptic application when changing catheter dressing

Other names: Biseptine

disinfection efficacy using Amukin

Procedure

Detersion and antiseptic application when changing catheter dressing

Other names: Amukin

Primary outcomes

  1. Efficacy on skin colonization of two commercially available antiseptics

    Time frame: 2 weeks

Secondary outcomes

  1. In case of nosocomial infection, relationship with skin bacteria

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Maternite Regionale Universitaire

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 19, 2006
Registry last updated
Sep 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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