Department of Surgery, University of Munich, Klinikum Großhadern, Marchioninistr. 15, 81377 Munich, Germany.
Langenbecks Arch Surg. 2011 Oct;396(7):1055-60. doi: 10.1007/s00423-010-0720-4. Epub 2010 Dec 1.
Ethanol- or 1-propanol-containing hand disinfectants are widely used as surgical hand antisepsis. The primary objective of this study was to investigate transdermal absorption of ethanol and 1-propanol from combination of 45% ethanol and 18% 1-propanol with skin protecting ingredients (Softa-Man®) within 1 h after application in comparison to the absorption of these alcohols from the product in the absence of the cosmetic additives. The secondary objective was to evaluate the dermal tolerability.
Following the double-blind, randomized cross-over design for this clinical trial, 20 ml of two different alcohol-containing disinfectants was applied with a 200-cm(2) gauze swab on a skin area, identical in size and location, of 14 healthy volunteers for 10 min to investigate the absorption rate of ethanol and 1-propanol. Local dermal tolerability was evaluated using a four-point erythema scale.
No clinically relevant dermal absorption, with respect to ethanol and 1-propanol, could be observed within 1 h after application. Disinfectant-related mild local skin erythema was observed in three cases.
The use of the tested formulations containing ethanol and 1-propanol can be considered as safe. The tested formulation containing skin protecting additives (Softa-Man®) does not result in more alcoholic absorption than the formulation without protective additives.
含乙醇或 1-丙醇的手部消毒剂广泛用于外科手消毒。本研究的主要目的是研究在应用后 1 小时内，与不含化妆品添加剂的产品相比，含有 45%乙醇和 18% 1-丙醇的组合与皮肤保护剂（Softa-Man®）联合使用时，这些醇类从皮肤中的经皮吸收情况。次要目的是评估皮肤耐受性。
在这项临床试验中，采用双盲、随机交叉设计，将两种不同的含酒精消毒剂各 20ml 用 200cm²的纱布拭子涂于 14 名健康志愿者相同大小和位置的皮肤区域，涂药 10 分钟，以研究乙醇和 1-丙醇的吸收率。采用四点红斑量表评估局部皮肤耐受性。
应用后 1 小时内，未观察到与乙醇和 1-丙醇相关的临床相关经皮吸收。在三种情况下观察到与消毒剂相关的轻度局部皮肤红斑。
使用含乙醇和 1-丙醇的测试配方可被认为是安全的。含有皮肤保护添加剂（Softa-Man®）的测试配方不会比不含保护添加剂的配方导致更多的酒精吸收。
