Effectiveness of Pre-surgical Hand Washing in Reducing Bacterial Load, Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate
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
- Change of bacterial load measured in CFU 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 propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of 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 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 addition of a solution of 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
- 是
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%
Effectiveness of pre-surgical hand washing in reducing bacterial load using propanolol-1 60% as control
干预措施: Hand antisepsis with Clorhexidine and solution (Drug)
Hand antisepsis with Clorhexidina and solution
chlorhexidine gluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate.
干预措施: Hand antisepsis with Clorhexidine and solution (Drug)
结局指标
主要结局
Change of bacterial load measured in CFU 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
- Change of bacterial loadmeaured in CFU after 3 hours of hand scrub(Change from bacterial load at 3 hours)
研究者
Ricardo Becerro de Bengoa Vallejo
Principal Investigator
Centro Ortopedico y Quirurgico del Pie