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
|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)|
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 Type :||Observational|
|Estimated Enrollment :||30 participants|
|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|
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
- 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.
- 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.
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
|Contact: Stéphane Blanot, MD||+33 1 44 49 47 email@example.com|
|Contact: Hélène Morel||+33 1 71 19 63 firstname.lastname@example.org|
|Hôpital Necker-Enfants Malades||Not yet recruiting|
|Paris, France, 75015|
|Contact: Stéphane Blanot +33 1 44 49 47 68 email@example.com|
|Contact: Hélène Morel +33 1 71 19 63 46 firstname.lastname@example.org|
|Principal Investigator:||Stéphane Blanot, MD||Assistance Publique - Hôpitaux de Paris|
|Study Director:||Edouard Jullien||Assistance Publique - Hôpitaux de Paris|