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Completed

NCT Number: NCT04117776

Skin Decolonization of Children Hospitalized in Intensive Care Unit

The purpose of this study is to evaluate the efficacy and duration of the skin decolonization brought by a daily wash using Chlorhexidine Gluconate 2% pad compared to a standard wash with mild soap in children hospitalized in intensive care unit.

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Key information

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

Skin is a major reservoir of pathogenic bacteria and intensive care unit patients are particularly vulnerable to variations in skin colonization and so to infections. These bacterial skin colonizations can contaminate other patients, nursing staff or even samples, but above all they are an endogenous source of infection of material. These bacterial skin colonizations hold therefore a major place in the responsibility of infections associated with care and can potentially affect the length of patient hospitalization. 2% Chlorhexidine Gluconate pads have already demonstrated a real efficacy in the sustainable reduction of central venous catheter-related bacteremias in adults and in children, probably through a reduction of cutaneous microbial colonization. However, this hypothesis remains to be confirmed.

Patients in the pediatric surgical intensive care unit of Necker-Enfants Malades hospital are minors, hospitalized in critical and continuous surgical surveillance unit, for all surgical specialties excluding cardiac surgery. The use of central venous catheters concerns approximately 60% of the hospitalization days identified each year. To control catheter-related bacteremias, all intensive care unit patients are subjected to a service protocol since 2015, which defines a mild soap daily wash in patients without central venous catheter and a wash with Chlorhexidine in patients with central venous catheter. Successive standardized samples will be carried out on the skin of the children submissive to both types of washes during their hospitalization in intensive care unit.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients from 0 to 17 years old
  • Hospitalized in the pediatric surgical intensive care unit of the Necker Hospital for a duration of at least 5 days
  • Patients likely to receive the 2 types of washes (mild soap and Chlorhexidine Gluconate )
  • Patients subject to the service wash protocol for at least two daily washes (24 hours)

Exclusion criteria

  • Patients not following the 2 types of washes
  • Chronic skin lesions
  • Refusal to participate expressed by the holders of the parental authority and/or patient
  • not respecting the 24h imposed for each wash

Treatment and study plan

Skin microbiological sampling (wash with 2% Chlorhexidine Gluconate)

Other

3 microbiological samples, per application of agar on skin, after 24h of a first wash with 2% Chlorhexidine Gluconate : 1h before the second wash with the same washing product and then 1 to 2 h after, and 20 to 23h after this second wash.

Other names: Skin microbiological sampling

Skin microbiological sampling (wash with mild soap)

Other

3 microbiological samples, per application of agar on skin, after 24h of a first wash with mild soap : 1h before the second wash with the same washing product and then 1 to 2 h after, and 20 to 23h after this second wash.

Other names: Skin microbiological sampling

Primary outcomes

  1. Cutaneous colonization

    Time frame: 6 months

    Number of colony-forming unit after 24 hours of culture of 3 samples : 1 hour before the wash (mild soap or 2% Chlorhexidine Gluconate), 1 to 2 hours after, and 20 to 23 hours after the wash.

  2. Bacterial ecology

    Time frame: 6 months

    Macroscopic bacterial identification after Gram staining, after 24 hours of culture of 3 samples : 1 hour before the wash (mild soap or 2% Chlorhexidine Gluconate), 1 to 2 hours after, and 20 to 23 hours after the wash.

    Microbiological identification if the macroscopic appearance seems atypical.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Skin Decolonization of Children Hospitalized in Intensive Care Unit by Daily Toilet : Mild Soap Versus Chlorhexidine Gluconate 2% Pad

Acronym: DCpedrea

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 7, 2019
Registry last updated
Sep 12, 2025

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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