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临床试验/NCT04117776
NCT04117776已完成不适用

Skin Decolonization of Children Hospitalized in Intensive Care Unit by Daily Toilet : Mild Soap Versus Chlorhexidine Gluconate 2% Pad

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Cutaneous colonization

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •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

结局指标

主要结局

Cutaneous colonization

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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