BACKGROUND AND AIMS: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
RCT Entities:
BACKGROUND AND AIMS: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Authors: Martin Hartwig Kirschner; Reinhold Andreas Lang; Burkhard Breuer; Marion Breuer; Corinna Schulze Gronover; Thomas Zwingers; Johannes Georg Böttrich; Andreas Arndt; Ute Brauer; Matthias Hintzpeter; Marc-Alexander Burmeister; Jan-Dirk Fauteck Journal: Langenbecks Arch Surg Date: 2007-11-08 Impact factor: 3.445