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Double-Blind, Randomized, Crossover Trial of 3 Hand Rub Formulations: Fast-Track Evaluation of Tolerability and Acceptability

Published online by Cambridge University Press:  02 January 2015

Didier Pittet ,
Benedetta Allegranzi ,
Hugo Sax ,
Marie-Noelle Chraiti ,
William Griffiths ,
Hervé Richet  and
World Health Organization Global Patient Safety Challenge Alcohol-Based Handrub Task Force
Didier Pittet*
Affiliation:
Infection Control Program, University of Geneva Hospitals, Geneva, Switzerland Global Patient Safety Challenge, World Health Organization (WHO) World Alliance for Patient Safety, WHO Headquarters, Geneva, Switzerland
Benedetta Allegranzi
Affiliation:
Global Patient Safety Challenge, World Health Organization (WHO) World Alliance for Patient Safety, WHO Headquarters, Geneva, Switzerland
Hugo Sax
Affiliation:
Infection Control Program, University of Geneva Hospitals, Geneva, Switzerland
Marie-Noelle Chraiti
Affiliation:
Infection Control Program, University of Geneva Hospitals, Geneva, Switzerland
William Griffiths
Affiliation:
Global Patient Safety Challenge, World Health Organization (WHO) World Alliance for Patient Safety, WHO Headquarters, Geneva, Switzerland
Hervé Richet
Affiliation:
Global Patient Safety Challenge, World Health Organization (WHO) World Alliance for Patient Safety, WHO Headquarters, Geneva, Switzerland
*
Infection Control Program, University of Geneva Hospitals, 24 Rue Micheli-du-Crest, 1211 Geneva 14, Switzerland ([email protected])
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Abstract

Objective.

To compare healthcare workers' skin tolerance for and acceptance of 3 alcohol-based hand rub formulations.

Design.

Double-blind, randomized, crossover clinical trial.

Setting.

Intensive care unit in a university hospital.

Participants.

Thirty-eight healthcare workers (HCWs).

Intervention.

A total of 3 alcohol-based hand rub formulations (hereafter, formulations A, B, and C) were used in random order for 3-5 consecutive working days during regular nursing shifts. Formulations A and B contained the same emollient, and formulations B and C contained the same alcohol at the same concentration. Use of each test formulation was separated by a “washout” period of at least 2 days. A visual assessment of skin integrity by a blinded observer using a standard 6-item scale was conducted before and after the use of each formulation. Univariate and multivariate analyses were used for the assessment of risk factors for skin alteration, and product acceptability was assessed by use of a customized questionnaire after the use of each formulation.

Results.

Thirty-eight HCWs used each of 3 formulations for a median of 3 days (range, 3-5 days). The mean amount of product used daily (±SD) was 54.9 ± 23.5 mL (median, 50.9 mL). Both subjective and objective evaluation of skin conditions after use showed lower HCW tolerance for product C. Male sex (odds ratio [OR], 3.17 [95% confidence interval {CI}, 1.1-8.8]), fair or very fair skin (OR, 3.01 [95% CI, 1.1-7.9]), skin alteration before hand rub use (OR, 3.73 [95% CI, 1.7-8.1]), and use of formulation C (OR, 8.79 [95% CI, 2.7-28.4]) were independently associated with skin alteration.

Conclusions.

This protocol permits a fast-track comparison of HCWs' skin tolerance for different alcohol-based hand rub formulations that are used in healthcare settings. The emollient in formulation C may account for its inferior performance.

Type
Original Articles
Information
Infection Control & Hospital Epidemiology , Volume 28 , Issue 12 , December 2007 , pp. 1344 - 1351
Copyright
Copyright © The Society for Healthcare Epidemiology of America 2007

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