Institute of Hygiene and Applied Immunology, Medical University of Vienna, Vienna, Austria.
Infect Control Hosp Epidemiol. 2013 Mar;34(3):245-50. doi: 10.1086/669528. Epub 2013 Jan 18.
The World Health Organization (WHO) has published "Guidelines on Hand Hygiene in Health Care" recommending 2 hand rub formulations based on 80% vol/vol ethanol or 75% vol/vol isopropanol for local production in healthcare settings where commercial products are not available or are too expensive. Previous investigations have shown that neither formulation meets the efficacy requirements of European norm (EN) 12791, which is the most stringent available norm for surgical hand rub preparations. Even when modified with approximately 5% higher alcohol content, the formulations proved to be inferior to the reference of the norm when measured after 3 hours.
Because the high glycerol content of the formulations was suspected to negatively influence their efficacy, additional investigations were performed with varying glycerol content.
Modified formulations with higher alcohol concentration (mass instead of volume percentage) and lower glycerol concentration (0.725% instead of 1.45%) or without the addition of glycerol were evaluated for their conformity with the efficacy requirements of EN 12791, which demands noninferiority in comparison with a reference hand antisepsis procedure immediately and 3 hours after treatment on volunteers' hands.
Randomized Latin-square design.
Microbiology laboratory of the Medical University of Vienna, Vienna, Austria.
Twenty-five healthy volunteers.
Reducing the concentration of glycerol or omitting it completely rendered both WHO formulations noninferior to the reference, both immediately and 3 hours after surgical hand antisepsis.
Both WHO-recommended formulations meet the efficacy requirements of EN 12791 by increasing their alcohol concentrations by 5%, prolonging their application to 5 minutes and reducing the glycerol concentration to 0.725%.
世界卫生组织（WHO）发布了“医疗卫生保健用手卫生指南”，推荐了两种基于 80%vol/vol 乙醇或 75%vol/vol 异丙醇的手揉搓制剂，用于在商业产品不可用或过于昂贵的医疗卫生保健环境中进行本地生产。之前的调查表明，这两种制剂均不符合欧洲标准（EN）12791 的功效要求，EN12791 是用于手术手揉搓制剂的最严格的现有标准。即使用大约 5%更高的酒精含量进行改良，在 3 小时后测量时，这些制剂的效果仍不如该标准的参考制剂。
由于怀疑制剂中的高甘油含量会对其功效产生负面影响，因此进行了更多的调查，以研究不同的甘油含量。
评估了具有更高酒精浓度（质量而非体积百分比）和更低甘油浓度（0.725%而非 1.45%）的改良制剂，或不添加甘油的制剂，以评估其是否符合 EN12791 的功效要求，该标准要求在志愿者手上进行即时和处理后 3 小时的治疗时，与参考手部消毒程序相比具有非劣效性。
随机拉丁方设计。
奥地利维也纳医科大学微生物学实验室。
25 名健康志愿者。
降低甘油浓度或完全不添加甘油可使两种 WHO 制剂在即时和手术手消毒后 3 小时均与参考制剂具有非劣效性。
通过将酒精浓度提高 5%、将应用时间延长至 5 分钟并将甘油浓度降低至 0.725%，两种 WHO 推荐的制剂均符合 EN12791 的功效要求。
