Skin Decolonization of Children Hospitalized in Intensive Care Unit

NCT ID: NCT04117776

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-17
• Study Completion Date: 2020-07-17

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.

Conditions

Central Venous Catheter

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Patient benefiting during the same hospitalization of the loss or the gain of a central venous catheter.

Skin microbiological sampling (wash with 2% Chlorhexidine Gluconate)

Intervention Type: 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.

Skin microbiological sampling (wash with mild soap)

Intervention Type: 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.

Interventions

Skin microbiological sampling (wash with 2% Chlorhexidine Gluconate)

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.

Intervention Type: OTHER

Skin microbiological sampling (wash with mild soap)

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.

Intervention Type: OTHER

Other Intervention Names

Skin microbiological sampling; Skin microbiological sampling

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphane Blanot, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Edouard Jullien

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Necker-Enfants Malades

Paris, Paris, France

Countries

France

Other Identifiers

2019-A00844-53

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190298

Identifier Type: -

Identifier Source: org_study_id