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Skin Decolonization of Children Hospitalized in Intensive Care Unit (DCpedrea)

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ClinicalTrials.gov Identifier: NCT04117776
Recruitment Status : Not yet recruiting
First Posted : October 7, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Central Venous Catheter Other: Skin microbiological sampling (wash with 2% Chlorhexidine Gluconate) Other: Skin microbiological sampling (wash with mild soap)

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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Skin Decolonization of Children Hospitalized in Intensive Care Unit by Daily Toilet : Mild Soap Versus Chlorhexidine Gluconate 2% Pad
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Group/Cohort Intervention/treatment
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)
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 Name: Skin microbiological sampling

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.
Other Name: Skin microbiological sampling




Primary Outcome Measures :
  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.




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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Minors hospitalized in intensive care unit of Necker Hospital.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117776


Contacts
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Contact: Stéphane Blanot, MD +33 1 44 49 47 68 stephane.blanot@aphp.fr
Contact: Hélène Morel +33 1 71 19 63 46 helene.morel@aphp.fr

Locations
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France
Hôpital Necker-Enfants Malades Not yet recruiting
Paris, France, 75015
Contact: Stéphane Blanot    +33 1 44 49 47 68    stephane.blanot@aphp.fr   
Contact: Hélène Morel    +33 1 71 19 63 46    helene.morel@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Stéphane Blanot, MD Assistance Publique - Hôpitaux de Paris
Study Director: Edouard Jullien Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04117776     History of Changes
Other Study ID Numbers: APHP190298
2019-A00844-53 ( Other Identifier: IDRCB number )
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Central venous catheter-related bacteremias
Skin decolonization
Intensive care unit hospitalization
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents