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临床试验/NCT02294604
NCT02294604已完成不适用

The Antiseptic Outcome of Traditional Hand Scrubbing Versus Hand Rubbing in Surgical Room

Taipei Medical University Shuang Ho Hospital0 个研究点目标入组 236 人开始时间: 2015年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
236
主要终点
Microorganisms on Hands Before Scrubbing

研究概览

简要总结

Hand hygiene is the cornerstone of aseptic techniques to reduce surgical site infection. The traditional surgical antisepsis involves scrubbing the skin with povidone-iodine or chlorhexidine gluconate. Recently, a waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers was developed to provide a comparable antiseptic effect. The investigators perform a randomized controlled trial to compare the antiseptic effectiveness of the waterless hand rubbing, the classic surgical handwashing with povidone-iodine and chlorhexidine solutions.

详细描述

This single centre, randomized trial recruited surgical team members in Taipei Medical University-Shuang Ho Hospital at November 2014. 255 episodes of hand washing are enrolled. The participants are assigned equally to use either a waterless hand rub (Group R), or traditional scrub formation with 10 % povidone-iodine (Group I) and 4% chlorhexidine (Group C). Hand washing time, microorganisms on hands before and after scrubbing is recorded. The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates after hand washing. The secondary outcomes is hand microbial flora after surgery and duration of hand washing.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Surgical staff members, both surgeons and scrub nurses

排除标准

  • Participants were excluded if they were medical or nursing students
  • Allergy to the experimental materials

结局指标

主要结局

Microorganisms on Hands Before Scrubbing

时间窗: 2 days after sampling

The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates

次要结局

  • Duration of Hand Washing(Immediately)
  • Microorganisms on Hands After Scrubbing(2 days after sampling)
  • Microorganisms on Hands After Surgery(2 days after sampling)

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ka-Wai Tam

Director of Center for Evidence-Based Health Care

Taipei Medical University Shuang Ho Hospital

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