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1.
Langenbecks Arch Surg ; 396(7): 1055-60, 2011 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-21116645

RESUMO

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.


Assuntos
1-Propanol/farmacocinética , Anti-Infecciosos Locais/farmacocinética , Etanol/farmacocinética , Absorção Cutânea/efeitos dos fármacos , 1-Propanol/farmacologia , Adulto , Antropometria , Anti-Infecciosos Locais/farmacologia , Índice de Massa Corporal , Estudos Cross-Over , Método Duplo-Cego , Etanol/farmacologia , Desinfecção das Mãos/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Sensibilidade e Especificidade , Adulto Jovem
2.
Langenbecks Arch Surg ; 394(1): 151-7, 2009 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-17989993

RESUMO

BACKGROUND AND AIMS: Ethanol- or 2-propanol-containing disinfectant agents are widely used in medical practice, particularly in the surgical environment. It was the primary objective of this phase I study to comparatively investigate the transdermal resorption of ethanol and 2-propanol within 1 h after dermal application of the two agents as single preparations and a commercial product containing both alcohols in combination, respectively. The secondary objective was to examine whether a mutual influence of the two alcohols in combination exists. MATERIALS AND METHODS: Following the double-blind, randomized, three-times cross-over design for this clinical trial, 20 ml of three different alcohol-containing disinfectants were applied on a 200-cm(2) gauze swab on skin areas, identical in size and location, of 14 healthy volunteers for 10 min to investigate the absorption rate of ethanol and 2-propanol with special focus on the question whether the two alcohols might influence each other's absorption rate when being applied in combination. RESULTS: No clinically relevant enhancement of dermal absorption, with respect to ethanol and 2-propanol, could be observed within 1 h after application, neither when used as single preparations, nor in combination. CONCLUSION: Therefore, the use of ethanol- and 2-propanol-containing disinfectants in the medical environment can be considered as safe.


Assuntos
2-Propanol/farmacocinética , Desinfetantes/farmacocinética , Etanol/farmacocinética , Absorção Cutânea/fisiologia , Acetona/farmacocinética , Adulto , Área Sob a Curva , Estudos Cross-Over , Método Duplo-Cego , Interações Medicamentosas , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
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