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临床试验/NCT04446923
NCT04446923已完成4 期

Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing in Accordance With European Norm Regulation 12791

Universidad Complutense de Madrid1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年6月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Reduction of bacterial load immediately after hand scrub

研究概览

简要总结

The present study evaluates the effects of to compare bactericidal efficacy using the reference antiseptic product propan-ol-1 60% using the hand rub method versus hand scrub method in order to test if pass the standard european norm 12791.

详细描述

The investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by rub and scrub. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The samples will be sent to the laboratory with numbers.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants without systemic pathologies, with healthy skin of the hands and short fingernails.
  • They do not use substances with antibacterial action.

排除标准

  • Taken antibiotics before 10 days of the intervention.
  • Wear any jewellery on the hands.

研究组 & 干预措施

Hand antisepsis by scrub

Experimental

Hand antisepsis by scrub using propan-ol-1 60%

干预措施: Hand antisepsis by scrub (Drug)

Hand antisepsis by rub

Active Comparator

Hand antisepsis by rub using propan-ol-1 60%

干预措施: Hand antisepsis by scrub (Drug)

结局指标

主要结局

Reduction of bacterial load immediately after hand scrub

时间窗: Change from bacterial load at 5 minutes.

Participants will scrub the liquid vigorously from hand to the wrists according with the standard handrub procedure.

次要结局

  • Reduction of bacterial load after 3 hours of hand scrub(Change from bacterial load at 3 hours.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

César Calvo Lobo

Principal Investigator

Universidad Complutense de Madrid

研究点 (1)

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