Clinical trial NCT04117776: Skin Decolonization of Children Hospitalized in Intensive Care Unit
Official title: Skin Decolonization of Children Hospitalized in Intensive Care Unit by Daily Toilet : Mild Soap Versus Chlorhexidine Gluconate 2% Pad
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Venous Catheter
Keywords: Central venous catheter-related bacteremias
Skin decolonization
Intensive care unit hospitalization
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 34
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minors hospitalized in intensive care unit of Necker Hospital.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cutaneous colonization
timeFrame: 6 months
measure: Bacterial ecology
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Stéphane Blanot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Edouard Jullien
role: STUDY_DIRECTOR
References: