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

Abstract

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.

Hand Hygiene

“…In a recent study conducted among ICU HWs, the short-term skin tolerability and acceptability of the WHO-recommended handrub formulations were significantly higher than those of a reference product 504 . Lessons learnt about acceptability and tolerability of the WHO-recommended formulations in some sites where local production has taken place are summarized below (Section 12.2).…”

“…A more investigational protocol has been designed to make a fast-track comparison of two or more products using a double-blind, randomized, cross-over methodology. 504 Hand hygiene products damage the skin by causing denaturation of stratum corneum proteins, changes in intercellular lipids (either depletion or reorganization of lipid moieties), decreased corneocyte cohesion and decreased stratum corneum water-binding capacity. 574,576 Among these, the main concern is the depletion of the lipid barrier that may be consequent to contact with lipid-emulsifying detergents and lipid-dissolving alcohols.…”

“…578 Numerous reports confirm that alcohol-based formulations are well tolerated and often associated with better acceptability and tolerance than other hand hygiene products. 504,548,[579][580][581][582][583][584] In general, irritant contact dermatitis is more commonly reported with iodophors 220 Other antiseptic agents that may cause irritant contact dermatitis, in order of decreasing frequency, include chlorhexidine, chloroxylenol, triclosan, and alcoholbased products. Skin that is damaged by repeated exposure to detergents may be more susceptible to irritation by all types of hand antisepsis formulations, including alcohol-based preparations.…”

“…577 In a recent study conducted among ICU HCWs, the short-term skin tolerability and acceptability of the WHO-recommended alcohol-based formulations (see Section 12) were significantly higher than those of a reference product. 504 Risk factors identified for skin alteration following handrub use were male sex, fair and very fair skin, and skin alteration before use.…”

“…Characteristics that can affect HCWs' acceptance of a hand hygiene product include dermal tolerance and skin reactions to the product, and its characteristics such as fragrance, consistency, and colour, 220,493,504,598,610 Structured, self-administered questionnaires may be useful tools to assess HCWs' acceptability of hand hygiene products. A standardized and validated survey to evaluate acceptability and tolerability among HCWs is available within the Implementation Toolkit (http://www.who.…”