Skin Decolonization of Children Hospitalized in Intensive Care Unit

Completed

• Conditions: Central Venous Catheter
• Interventions: Other: Skin microbiological sampling (wash with 2% Chlorhexidine Gluconate); Other: Skin microbiological sampling (wash with mild soap)

• Registration Number: NCT04117776
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Status Verified: 2020-01
• Study Start: 2020-01-17
• Primary Completion: 2020-07-17
• Study Completion: 2020-07-17
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Skin microbiological sampling (wash with mild soap)	Patient benefiting during the same hospitalization of the loss or the gain of a central venous catheter.
Patients	Skin microbiological sampling (wash with 2% Chlorhexidine Gluconate)	Patient benefiting during the same hospitalization of the loss or the gain of a central venous catheter.

Primary Outcome Measures

Name	Time	Method
Cutaneous colonization	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.
Bacterial ecology	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.

Trial Locations

Locations (1)

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France