Hennig Thomas-Jörg, Werner Sebastian, Naujox Kathrin, Arndt Andreas
B. Braun Medical AG, Centre of Excellence Infection Control, Seesatz 17, 6204 Sempach, Switzerland.
HygCen Germany GmbH, Bornhövedstrasse 78, 19055 Schwerin, Germany.
Antimicrob Resist Infect Control. 2017 Sep 13;6:96. doi: 10.1186/s13756-017-0258-0. eCollection 2017.
Surgical hand preparation is an essential part of modern surgery. Both alcohol-based and antiseptic detergent-based hand preparation are recommended practices, with a trend towards use of alcohol based handrubs. However, discussion has arisen whether chlorhexidine is a required ingredient in highly efficacious alcohol-based formulations, in view of providing sustained antimicrobial efficacy.
One alcohol-only formulation (product A), containing ethanol and n-propanol, and one formulation containing a chlorhexidine-ethanol combination (product B) were directly compared with each other using a modified test protocol based on European standard EN 12791 (2016) with 25 volunteers. The alcohol-only formulation (product A) was applied for only 90 s, the chlorhexidine-alcohol formulation (product B) for 180 s. Microbial log reduction factors were determined and statistically compared immediately after application and at 6 h under surgical gloves.
The alcohol-only formulation (product A) achieved mean log reduction factors of 1.96 ± 1.06 immediately after application and 1.67 ± 0.71 after 6 h. The chlorhexidine-alcohol combination (product B) achieved mean log reduction factors of 1.42 ± 0.79 and 1.24 ± 0.90 immediately and after 6 h, respectively. The values for product A were significantly greater than those for product B at both measured time points ( ≤ 0.025 immediately after application and ≤ 0.01 after 6 h).
An optimized alcohol-only formulation tested according to a modified EN 12791 protocol in 25 healthy volunteers outperformed a chlorhexidine-alcohol formulation both immediately after application and at 6 h under surgical gloves, despite a much shorter application time. Thus, optimized alcohol-only formulations do not require chlorhexidine to achieve potent immediate and sustained efficacy. In conclusion, chlorhexidine is not an essential component for alcohol-based surgical hand preparation.
外科洗手准备是现代外科手术的重要组成部分。基于酒精和基于抗菌洗涤剂的洗手准备都是推荐的做法,且有使用酒精擦手液的趋势。然而,鉴于要提供持续的抗菌效果,对于洗必泰是否是高效酒精基配方中必需的成分存在争议。
使用基于欧洲标准EN 12791(2016)的改良测试方案,将一种仅含酒精的配方(产品A,含有乙醇和正丙醇)和一种含洗必泰 - 乙醇组合的配方(产品B)直接在25名志愿者身上进行比较。仅含酒精的配方(产品A)应用90秒,洗必泰 - 酒精配方(产品B)应用180秒。测定微生物对数减少因子,并在应用后立即以及戴手术手套6小时后进行统计学比较。
仅含酒精的配方(产品A)在应用后立即实现的平均对数减少因子为1.96±1.06,6小时后为1.67±0.71。洗必泰 - 酒精组合(产品B)在应用后立即和6小时后的平均对数减少因子分别为1.42±0.79和1.24±0.90。在两个测量时间点,产品A的值均显著高于产品B的值(应用后立即≤0.025,6小时后≤0.01)。
根据改良的EN 12791方案在25名健康志愿者身上测试的优化的仅含酒精配方,尽管应用时间短得多,但在应用后立即以及戴手术手套6小时后均优于洗必泰 - 酒精配方。因此,优化的仅含酒精配方不需要洗必泰来实现强效的即时和持续效果。总之,洗必泰不是酒精基外科洗手准备的必需成分。