跳至主要内容
临床试验/NCT04538365
NCT04538365已完成4 期

Effect on the Reduction of Bacterial Load in Surgical Antisepsis of Hands After Washing With Triclosan 0.5% Compared to Propan-1-ol 60% Used as Reference Disinfectant

Centro Ortopedico y Quirurgico del Pie1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年10月1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
发起方
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 bactericidal load reduction after surgical hand scrub antisepsis using the reference antiseptic product propanol-

1 60% as control versus a surgical hand scrub antisepsis with triclosan 0.5% 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 scrub using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with trocilosan 0.5% in order to test if pass the standard european norm 12791. 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 60 Years(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 with propanolol-1 60%

Active Comparator

Effectiveness of pre-surgical hand washing in reducing bacterial load using propanolol-1 60% as control

干预措施: propanolol (Drug)

Hand antisepsis with triclosan solution

Experimental

Effectiveness of pre-surgical hand washing in reducing bacterial load using triclosan 0.5% solution

干预措施: Triclosan 0.5 % Topical Solution (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 with the antiseptic solution vigorously from hand to the wrists according with the standard handscrub procedure

次要结局

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

研究者

发起方
Centro Ortopedico y Quirurgico del Pie
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ricardo Becerro de Bengoa Vallejo

Principal Investigator

Centro Ortopedico y Quirurgico del Pie

研究点 (1)

Loading locations...

相似试验