EUCTR2020-000755-13-FR进行中(未招募)1 期
ESTIMATION OF THE INCIDENCE OF COLONIZATION OF PERIPHERAL VENOUS CATHETERS AFTER SKIN DISINFECTION WITH 0.5% SODIUM HYPOCHLORITE, PRECEDED OR NOT BY AN APPLICATION OF 70% ETHANOL: PILOT, MONOCENTRIC, RANDOMIZED, OPEN-LABEL STUDY - DACLEA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adult patient (=18 years old) requiring hospitalization in participating services
- •- Having an indication for the placement of a peripheral venous catheter for an expected duration of at least 48 hours
- •- Free subject, without guardianship or curatorship or subordination
- •- A person affiliated to or benefiting from a social security scheme.
- •- Having given free and informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •- Hypersensitivity to any of the constituents of Dakin® and/or Cooper® modified alcohol;
- •- History of epilepsy,
- •- Placement of a peripheral venous catheter in the emergency room that does not allow the usual rules of hygiene to be respected;
- •- Difficult vascular access foreseeable (drug addict, obese, non-visible veins...);
- •- Participation in another research protocol reducing the risk of catheter-related infection;
- •- Patient having received an antibiotic treatment in the 15 days prior to inclusion in the study;
- •- Patient who has already participated in the study;
- •- Subjects not affiliated with a Social Security system.
- •- Subjects benefiting from enhanced protection, namely persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection (guardianship and trusteeship) and finally patients in emergency situations.
- •- Pregnant or breastfeeding women, women of child-bearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy...).
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