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临床试验/NCT02500758
NCT02500758已完成不适用

Effectiveness of Preoperative Surgical Scrubbing in Reducing Bacterial Load, Using Chlorhexidine Digluconate (CHX) and Parachlorometaxylenol (PCMX)

Ricardo Becerro de Bengoa Vallejo0 个研究点目标入组 30 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
主要终点
Change in the Release of Skin Flora From the Hands From Baseline to 5 Minutes After Disinfection by Surgical Scrubbing (Time Frame- "Baseline and 5 Minutes").

研究概览

简要总结

Despite the wide variety of products and antiseptic agents, no agent is ideal for every situation. The investigators would like to evaluate the difference in reducing bacterial load, using 4% chlorhexidine digluconate and 3% parachlorometaxylenol after a preoperative surgical scrubbing.

详细描述

The investigators conducted a controlled, prospective, randomized study to evaluate the antiseptic effectiveness of preoperative surgical scrubbing using 4% chlorhexidine digluconate and 3% parachlorometaxylenol. Samples were taken from the hands of each volunteer after a preparatory handwash, pre-surgical scrubbing, post-surgical scrubbing and 3 hours after surgical scrubbing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • No systemic diseases.
  • Healthy skin on hands, without cuts or abrasions.
  • Short and clean fingernails.
  • No use of substances with antimicrobial action (e.g. medicated soaps or creams).

排除标准

  • History of eczema.
  • History of psoriasis.
  • Allergies to any of the ingredients of the solutions or contraindication to its use.

结局指标

主要结局

Change in the Release of Skin Flora From the Hands From Baseline to 5 Minutes After Disinfection by Surgical Scrubbing (Time Frame- "Baseline and 5 Minutes").

时间窗: 5 minutes

Number of colony-forming units (CFU) sampled up to 5 minutes after disinfection by surgical scrubbing using parachlorometaxylenol or clorhexidine digluconate. After surgical scrubbing and drying, the fingertips are rubbed (including that of the thumb) for 1 minute on the base of a Petri dish containing volumes of 1.0 ml and 0.1 ml of undiluted sampling fluid of TSB and 0.1 ml from its 10-1 dilution are plated out for quantitative culture in TSA.

次要结局

  • Change in the Release of Skin Flora From the Hands From Baseline to 3 Hours After Surgical Scrub Disinfection, Wearing Surgical Gloves (Time Frame- "Baseline and 3 Hours").(3 hours)

研究者

发起方
Ricardo Becerro de Bengoa Vallejo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ricardo Becerro de Bengoa Vallejo

Doctor of Podiatric Medicine

Universidad Complutense de Madrid

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