Skin Decolonization of Children Hospitalized in Intensive Care Unit

NCT04117776 | Completed

• 2 other identifiers: APHP1902982019-A00844-53
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Venous Catheter

Keywords

Central venous catheter-related bacteremias; Skin decolonization; Intensive care unit hospitalization

Outcome Measures

Primary Outcomes (2)

• Cutaneous colonization

  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.

  6 months

• Bacterial ecology

  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.

  6 months

Study Arms (1)

Patients

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

Other: Skin microbiological sampling (wash with 2% Chlorhexidine Gluconate); Other: Skin microbiological sampling (wash with mild soap)

Interventions

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.

Also known as: Skin microbiological sampling

Patients

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.

Also known as: Skin microbiological sampling

Patients

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Minors hospitalized in intensive care unit of Necker Hospital.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, Paris, 75015, France

Location

MeSH Terms

Interventions

Therapeutic Irrigation; chlorhexidine gluconate

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Stéphane Blanot, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Edouard Jullien

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: October 7, 2019
• Study Start: January 17, 2020
• Primary Completion: July 17, 2020
• Study Completion: July 17, 2020
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)