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临床试验/NCT04683146
NCT04683146Unknown4 期

Effectiveness of Pre-surgical Hand Washing in Reducing Bacterial Load, Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate

Centro Ortopedico y Quirurgico del Pie0 个研究点目标入组 24 人开始时间: 2021年3月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
24
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 antisepsis using the reference antiseptic product propanol- 1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, chlorhexidine digluconate and potassium sorbate 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 surgical hand antisepsis using propan-ol-1 60% by using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, chlorhexidine digluconate and potassium sorbate 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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants with healthy skin in both hands and short fingernails.
  • No use of antibacterial agents for at least three days before the intervention.
  • Not received antibiotic treatment for at least ten days before the intervention.

排除标准

  • Known systemic pathologies
  • Wearing hand jewelry on the hands
  • Allergy to any ingredient of which the solutions used in the clinical trial are composed
  • Cognitive and / or motor limitation that makes it impossible to carry out instructions for hand washing

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 propranolol- 1 60% as control.

干预措施: Hand antisepsis with Propanolol- 1 60%. (Drug)

Hand antisepsis with propanolol-1 60%

Active Comparator

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

干预措施: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate. (Drug)

Hand antisepsis with solution of alcohol, chlorhexidine digluconate and potassium sorbate

Active Comparator

Effectiveness of pre-surgical hand washing in reducing bacterial load using a solution of alcohol, chlorhexidine digluconate and potassium sorbate

干预措施: Hand antisepsis with Propanolol- 1 60%. (Drug)

Hand antisepsis with solution of alcohol, chlorhexidine digluconate and potassium sorbate

Active Comparator

Effectiveness of pre-surgical hand washing in reducing bacterial load using a solution of alcohol, chlorhexidine digluconate and potassium sorbate

干预措施: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate. (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 antiseptic solution 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

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

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