Microbiological Efficacy and Tolerability of a New, Non Alcohol-Based Hand Disinfectant

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1 infection control and hospital epidemiology july 2009, vol. 30, no. 7 original article Microbiological Efficacy and Tolerability of a New, Non Alcohol-Based Hand Disinfectant Niina Agthe, RN; Kirsi Terho, MNSc; Tiina Kurvinen, MNSc; Marianne Routamaa, MNSc; Reijo Peltonen, MD, PhD; Kirsi Laitinen, PhD; Mari Kanerva, MD, PhD objective. Alcohol-based hand disinfectants are widely used in hospitals. Occasionally, there is a need for non alcohol-based products, but alternatives have been scarce. We studied the microbiological efficacy and tolerability of a water-based hand disinfectant for healthcare workers. design. A water-based hand disinfectant was introduced as the only hand disinfectant in 5 wards in Turku University Hospital, Finland. Ninety-nine healthcare workers participated in fingerprint sampling during the 7-week study period. In another ward, 26 healthcare workers who were using alcohol-based hand disinfectant acted as control subjects for the skin reaction studies. The water-based product was tested in the laboratory according to the European standard EN We obtained 292 fingerprint samples before and 302 after. The opinions of healthcare workers were collected by use of a questionnaire, and skin reactions were assessed subjectively by use of questionnaires and objectively by measuring moisture and transepidermal water loss. results. When tested in accordance with the European standard, the product met the requirements for short-term and long-term efficacy. The results of the fingerprint test showed that there was a statistically significant decrease in colonization of the fingertips before and after ( P!.001). The users of the water-based hand disinfectant reported dry skin more often than did control subjects, but visual inspection and the results of the moisture measurement showed no difference between the users of the water-based hand disinfectant and the control subjects. Transepidermal water loss measurement also showed no deterioration of skin condition. conclusions. The water-based hand disinfectant was shown to be an effective hand disinfectant that caused relatively little skin irritation and can serve as a hand hygiene alternative in situations in which alcohol-based disinfectant cannot be used. Infect Control Hosp Epidemiol 2009; 30: Hand is one of the most important infection control methods in health care. The method preferred in Finland and recommended in Europe and the United States is the use of an alcohol-based handrub before and after patient contact. Healthcare workers (HCWs) use hand disinfectants several times per work shift, and this practice exposes their skin to irritation and drying. 1 To minimize these problems, it is essential to select hand hygiene products accordingly and to train HCWs to avoid unnecessary washing with water and soap. Alcohol-based handrubs have been used for decades, and they are well tolerated. 2 Occasionally (eg, in psychiatric wards, day care centers, and institutions for alcoholics), there is a need for non alcohol-based products. Hitherto, there have been only a few choices for hand other than alcohol-based handrub. The effects of hand disinfectants have been studied extensively in Europe and in the United States. 1,3,4 The study methods have been both objective (use of an external inspector, a contact allergy test, or a device to measure transepidermal water loss [TEWL] or moisture) and subjective (use of questionnaires). 3,5,6 The activity of a new water-based hand disinfectant (Desisoft; Soft Protector) is based on polyhexamethylene guanidine. A similar type of guanidine-based disinfectant (Akacid; Airtech) has been studied elsewhere. 7-9 The aim of this study was to evaluate the microbiological efficacy of the waterbased hand disinfectant in vivo and to evaluate the skin reaction of the HCWs who used it, with the aim of establishing it as an alternative to alcohol-based hand disinfectants in certain situations. From the Department of Public Health, Faculty of Medicine, University of Helsinki (N.A., K.L.), and the Department of Medicine, Division of Infectious Diseases, Helsinki University Central Hospital (M.K.), Helsinki, and the Department of Infection Control and Hospital Hygiene, Turku University Hospital, Turku (K.T., T.K., M.R., R.P.), Finland. Received July 28, 2008; accepted February 14, 2009; electronically published June 3, by The Society for Healthcare Epidemiology of America. All rights reserved X/2009/ $ DOI: /598239

2 686 infection control and hospital epidemiology july 2009, vol. 30, no. 7 table. Colony-Forming Units (cfu) Recovered from Hands of Healthcare Workers After Use of Water-Based Disinfectant No. of cfu Before (n p 64) No. (%) of samples First sampling Second sampling Third sampling After (n p 67) Before (n p 33) After (n p 33) Before (n p 42) After (n p 46) (50) 60(90) 19(58) 29(88) 23(55) 43(93) (27) 3 (4) 7 (21) 3 (9) 16 (38) 3 (7) (17) 4 (6) 6 (18) 1 (3) 3 (7) 0 (0) x200 4(6) 0(0) 1(3) 0(0) 0(0) 0(0) note. Each sample represents both hands of a healthcare worker. methods The water-based hand disinfectant was introduced as the only hand disinfectant for 7 weeks for 99 HCWs in 5 wards of the Turku University Hospital (Turku, Finland). Study wards comprised 2 acute care wards (1 pediatric intensive care unit and 1 internal medicine ward) and 3 nonacute care wards (2 psychiatric wards and 1 rehabilitation ward). One acute care ward (internal medicine) with 26 HCWs served as a control; these HCWs used the alcohol-based disinfectant normally used in all wards. After the exclusion of HCWs who were also working in nonstudy wards, all HCWs in the specified wards participated ( n p 125). Before the introduction of the water-based hand disinfectant, all HCWs participating in the study completed a questionnaire about demographic characteristics and hand hygiene behavior that included an estimate of how frequently they used soap and hand disinfectant. Also, the HCWs in all wards were trained in hand hygiene recommendations. Two study wards were visited twice and 3 were visited 3 times by a researcher (N.A.), who delivered the follow-up questionnaires and performed fingerprint sampling, skin moisture measurement, TEWL measurement, and skin inspection. The control ward was visited 3 times for skin moisture measurement, TEWL measurement, and skin inspection. There were approximately 2 weeks between the visits. The laboratory testing was performed in accordance with the European standard EN for chemical disinfectants and antiseptics, 10 which was established as follows: Twenty volunteers participated. A cross-over design was used, and the reference product was 60% n-propanol. A rest period of 2 weeks between product applications was used to allow regeneration of normal skin flora. First, the participants washed hands for 1 minute with soft soap (sapo kalinus). They dried their hands with a paper towel and then rubbed their fingertips for 1 minute on the bottom of a Petri dish containing 10 ml tryptic soy broth to assess the release of skin bacteria before treatment of the hands. Next, the participants disinfected hands with either the test product or the reference product. The product was pipetted into the hands, and rubbing was performed in accordance with EN 12791, keeping the skin moist throughout the 3-minute time. Samples from the fingertips of 1 hand were obtained to determine the bacterial count immediately after. This time, the sampling fluid contained neutralizing agent to eliminate the effect of the remaining disinfectant. The effectiveness of neutralizing agent was validated in accordance with the standard. After treatment, the other hand was protected from extraneous contamination by a surgical glove for 3 hours to determine the product s ability to sustain over time. The glove was then removed, and a sampling procedure similar to that used immediately after was performed on this hand. One ml of tryptic soy broth was pipetted onto soy agar plates; after 24 hours of incubation, the colony-forming units (cfu) were counted. In our study, fingerprint sampling was performed in the wards that were using the water-based hand disinfectant. Samples were obtained before and after from HCWs on duty during normal working activities. HCWs did not wash their hands before sampling. For some participants, several pairs of before-and-after samples were taken during patient care. Sometimes, samples were obtained only after. The first sampling took place approximately 2 weeks after the introduction of the water-based hand disinfectant. Overall, the hands of 99 HCWs were sampled on 3 different occasions, before and after. Fingerprints from the right and left hands were analyzed on separate blood agar plates. Plates were cultured at room temperature. After 48 hours, colony-forming units were counted or approximated (ie, counted when fewer than 100 cfu were present and approximated when at least 100 cfu were present; the scale for approximation was as follows: cfu, cfu, and at least 200 cfu). The plates were photographed for later inspection. The mean number of colony-forming units cultured from the fingerprints of the right and left hand were counted (or approximated), and the results were divided into 4 groups: low (0 10 cfu), medium (11 99 cfu), high ( cfu), and too numerous to count (x200 cfu) (Table). The mean was used in analysis, because of previously

3 water-based hand disinfectant 687 published data indicating that the colonization of the right hand is similar to the colonization of the left hand of the same person. 11 The skin of the HCWs in both the study and the control wards was evaluated objectively with a vapometer 12 (Vapo- Meter SWL4; Delfin Technologies) to measure TEWL, a moisture-measuring device 13 (MoistureMeter SC4; Delfin Technologies), and visual examination by an external inspector (N.A). The measurements were performed on the dorsal side of the hands of HCWs in the study and control wards and also on the forearms of HCWs in wards that were using the water-based hand disinfectant. HCWs forearms were not exposed to the water-based hand disinfectant and therefore could act as a control. TEWL measurements could not be performed for subjects with hairy hands ( n p 2). Moisture measurements could not be performed if the HCW had been working for an extended period while wearing gloves (n p 3). The possible effect of external temperature changes on skin condition was also evaluated. At the time of each examination, the hands of the HCWs were inspected to evaluate the degree of dryness and eczema by means of a 4-level scale. Subjects who participated at least twice in the measurements were included in the statistical analyses. The first and last measurement for each participant were analyzed. The subjective rating of skin condition was evaluated by use of 2 different questionnaires, one that addressed any underlying skin diseases and another that addressed changes in skin condition during the study period. The data was analyzed using SPSS, version (SPSS). The reduction in bacterial count after and the changes in bacterial counts during the intervention were analyzed by the use of the sign test. Changes in skin condition, as identified by TEWL and moisture measurements during the intervention, were assessed by use of the Mann-Whitney U test and the Wilcoxon matched-pairs signed-rank test, and HCW opinions on changes in skin condition were compared with those of control subjects by means of the x 2 test. results The results of the in vitro test performed in accordance with EN revealed that, after 3 minutes of, the mean logarithmic reduction factor for the reference product was 2.69 (standard deviation [SD], 1.36; standard error [SE], 1.83) and for the water-based hand disinfectant was 3.18 (SD, 0.98; SE, 0.22). After 3 hours, the mean logarithmic reduction factor for the reference product was 2.01 (SD, 1.83; SE, 0.41) and for the water-based hand disinfectant was 2.59 (SD, 1.12; SE, 0.25). According to the standard, for the test product to meet the requirements of the standard, the reduction factor for the test product must be the same or greater than that for the reference material. There were no statistically significant differences between the users of the water-based hand disinfectant and the control subjects with respect to mean age (40 vs 39 years; P 1.5) or mean number of years at work (16 vs 13 years; P 1.5). However, the mean frequency of self-reported hand was slightly higher for control subjects than for users of the water-based hand disinfectant (48 [SD, 23; SE, 4.5] vs 35 [SD, 35; SE, 3.5] times per work shift; P p.03]). The prevalence of skin problems did not differ between the users of the water-based hand disinfectant wards and the control subjects (26% vs 30%; P 1.5). We obtained a total of 268 fingerprint samples from both hands of 52 HCWs in the first sampling session, 139 samples from 30 HCWs in the second session, and 190 samples from 40 HCWs in the third session. Altogether, 292 samples were obtained before and 302 after. The participants used the water-based hand disinfectant for a mean of 9 work shifts before the first session, 16 shifts before the second session, and 25 shifts before the third session. Colonization of the fingertips was reduced after ( P!.001) (Table). In addition, the prevalence of colonization before decreased throughout the study period, although the reduction was not statistically significant. TEWL (for 83 users of the water-based hand disinfectant and 24 control subjects) and the moisture content (for 82 users of the water-based hand disinfectant and 25 control subjects) were measured for those HCWs present at the time of the researcher s visit (4 times in 4 wards and 3 times in 2 wards). The same persons were not necessarily present at each testing session. Altogether, 201 TEWL measurements of hands and 155 of forearms were performed. Sixty-one HCWs participated twice in TEWL measurement during the study period. The TEWL of the individual participants changed between the first and the last measurement. The mean change among users of the water-based hand disinfectant was a decrease of 3.1 g/m 2 per hour (SD, 15.1), whereas the mean change among control subjects was an increase of 6.4 g/m 2 per hour (SD, 15.1) ( P p.031). The mean TEWL changed from 21.1 to 16.5 g/ m 2 per hour for users of the water-based hand disinfectant and 18.2 to 19.2 g/m 2 per hour for control subjects, from the first to the last measurement (Figure 1). This may indicate an improvement in skin condition among users of the water-based hand disinfectant. No statistically significant differences were observed between the dorsum of control subjects hands and the forearms of the users of the water-based hand disinfectant. Overall, 207 moisture measurements of hands and 184 of forearms were performed. Sixty-four subjects participated in the moisture measurements at least twice during the study period. According to the unitless index used by the manufacturer of the moisture-measuring device, normal healthy skin values vary from 20 to 50. The mean moisture content of hands decreased among both users of the water-based hand disinfectant and control subjects from 31.7 (SD, 18.0; SE, 2.1) to 16.8 (SD, 10.0; SE, 1.2) ( P!.001), but there

4 688 infection control and hospital epidemiology july 2009, vol. 30, no. 7 figure 1. Distribution of the measurements of transepidermal water loss (TEWL) for subjects who used water-based hand disinfectant and subjects who used alcohol-based disinfectant, for different measurement sessions. At the first session, we evaluated 56 users of the water-based hand disinfectant and 19 control subjects; at the second session, we evaluated 44 users of the water-based hand disinfectant and 9 control subjects; at the third session, we evaluated 28 users of the water-based hand disinfectant and 8 control subjects; and at the fourth session, we evaluated 32 users of the water-based hand disinfectant and 5 control subjects. The horizontal line in the middle of each box indicates the median, while the top and bottom borders of the box mark the 75th and 25th percentiles, respectively. The whiskers above and below the box mark the 90th and 10th percentiles, respectively. The points beyond the whiskers are outliers beyond the 90th or 10th percentiles. and 14 of 26 control subjects completed the questionnaire. Users of the water-based hand disinfectant reported drying and itching of the skin more often than did the control subjects (39% vs 17%; P p.019), but 5 of the users of the waterbased hand disinfectant reported that dryness was attributable to some reason other than the disinfectant, for example, working in the garden or handling irritating substances at home. discussion The water-based hand disinfectant was studied in the laboratory and in the hospital environment to assess its microbiological efficacy and tolerability. The water-based hand disinfectant was found to be microbiologically effective and not significantly irritative. The EN test showed that the microbiological efficacy of the water-based hand disinfectant against bacteria was at least as good as that of alcohol-based hand product. In the fingerprint sampling test, there were significantly fewer colony-forming units ( P!.001) after than before at each sampling time, showing in vivo efficacy. Colony-forming unit counts were also notably low before, compared with the results of studies by Pessoa-Silva et al. 14 and Kac et al. 15 These studies involved alcohol-based disinfectants under similar conditions and used a similar sampling method; their results showed that the number of colony-forming units before with alcohol was approximately 46 cfu to 144 cfu, whereas in our study were no differences between the groups. The decrease in moisture content observed on the forearms of the users of the water-based hand disinfectant was similar to that observed on the hands (Figure 2). During the study, the mean outdoor daytime temperature decreased from 16 C to6 C (Figure 3). The correlation between outdoor temperature and skin drying was strong (Pearson correlation coefficient, 0.857; P!.001). The external inspection for dryness and eczema of skin was performed at 4 different visits for a total of 174 times for 84 users of the water-based hand disinfectant and 43 times for 25 control subjects. The same persons were not necessarily present at each testing session. No statistically significant differences were observed between the groups. At the first examination, the self-evaluation questionnaire was completed by 55 HCWs who were using the water-based hand disinfectant and 8 control subjects. At the second examination, 28 users of the water-based hand disinfectant and 7 control subjects completed the questionnaire. At the end of the study, 50 users of the water-based hand disinfectant and 3 control subjects completed the questionnaire. Altogether, 79 of 125 users of the water-based hand disinfectant figure 2. Distribution of the skin moisture measurements for subjects who used water-based hand disinfectant and subjects who used alcohol-based disinfectant, for different measurement sessions. The first session had 58 participants, the second 43, the third 29, and the fourth 35. Note: There is no unit for the results of the measurement. The value of healthy skin varies from 20 to 50.

5 water-based hand disinfectant 689 figure 3. Mean temperatures in Turku, Finland, and the moisture content of hands of subjects who used water-based hand disinfectant and subjects who used alcohol-based disinfectant at different time points. Temperature data was obtained from the Finnish Meteorological Institute. The measurement site was in Artukainen, Turku, 5 km from the hospital. Note: There is no unit for the results of the measurement. The value of healthy skin varies from 20 to 50. with the water-based hand disinfectant, the median value was 12 cfu at the first and 6 cfu at the second and third sampling occasions. This may suggest that the water-based product has a long-lasting antibacterial effect, but this possibility could not be assessed by the data, because few participants were tested more than once during our study. HCWs subjective assessment revealed increased itching of the skin throughout the study period. One reason for this increase in itching may have been the decrease of the external temperature and the increase in the dryness of the indoor air. 1 The control subjects reported similar symptoms. The ingredients in alcohol-based hand products are different from those of the water-based hand disinfectant, and this difference might influence the feeling of the skin, because the main component of the water-based hand disinfectant is water. TEWL measurement methods assess the water-binding capacity of the skin, and an increase in TEWL indicates damage to the skin. The decrease in TEWL observed for the users of the water-based hand disinfectant suggests that the condition of their skin improved during the study period. One ingredient of the water-based hand disinfectant is creatin, which might explain the improvement but which should be studied additionally in the future. Self-reported hand hygiene compliance at the beginning of the study was slightly lower among the users of the water-based hand disinfectant. Theoretically, we cannot rule out this as a skin-sparing factor. In the moisture measurements, drying of the skin was seen among both users of the water-based hand disinfectant and control subjects. Like the itching, this might have been attributable to the decrease in outside temperature during the study period. Central heating and the drying of the indoor air also affect skin condition. Another reason for drying of the skin might have been changes in hand hygiene compliance. Our data did not include the amount of hand disinfectant used before and during the intervention, which would have permitted a comparison of possible changes in compliance. However, the users of the water-based hand disinfectant and the control subjects had the same training background on hand hygiene compliance before the study began. Our study also had some other limitations. The HCWs were very busy and worked in 3 shifts. Thus, it was difficult to reach the same HCWs during the study period, and this difficulty resulted in a loss of statistical power. The other limitation was the use of the fingerprint stamp on agar plates instead of the glove juice method. The glove juice method has been shown to be more accurate, but it may be disruptive and time consuming in a hospital environment. In the glove

6 690 infection control and hospital epidemiology july 2009, vol. 30, no. 7 juice method, the hand is inserted into a glove filled with a measured quantity of sterile water and massaged for 1 minute; the water is then cultured on plates. 16 When the agar plate method is used, the exact number of colony-forming units is difficult to count when the number is more than 100 cfu. To overcome this problem, we took photographs of the culture plates to count the colony-forming units and enlarged the pictures when necessary. Non alcohol-based products offer some advantages over conventional hand disinfectants: they are nonflammable and safe to store and transport as a concentrate. The desire to limit alcohol use because of religious reasons or fear of misuse is not an issue with the product. Thus, the water-based hand disinfectant could be used in psychiatric and rehabilitation units as an alternative to alcohol-based products. Also, in developing countries, the water-based hand disinfectant might have some advantages. Because of its high molecular weight, it is not likely to permeate glove materials, so it can be used as a disinfectant in places where gloves are reused. The water-based hand disinfectant is an effective, promising new product for hand. acknowledgments We thank the participants and the microbiological department at Turku University Hospital for offering us the culture media for our study. Financial support. Soft Protector (for the test product and resources for laboratory studies). Potential conflicts of interest. N.A. worked as a hand hygiene consultant for Soft Protector for a short period during the late stages of writing this article. All other authors report no conflicts of interest relevant to this article. Address reprint requests to Niina Agthe, RN, Department of Public Health, Faculty of Medicine, University of Helsinki, PO Box 41 (Mannerheimintie 172), FIN University of Helsinki, Finland. references 1. Larson E, Girard R, Pessoa-Silva CL, Boyce J, Donaldson L, Pittet D. Skin reactions related to hand hygiene and selection of hand hygiene products. Am J Infect Control 2006; 34: Houben E, De Paepe K, Rogiers V. Skin condition associated with intensive use of alcoholic gels for hand : a combination of biophysical and sensorial data. Contact Dermatitis 2006; 54: Grove GL, Zerweck CR, Heilman JM, Pyrek JD. Methods for evaluating changes in skin condition due to the effects of antimicrobial hand cleansers: two studies comparing a new waterless chlorhexidine gluconate/ ethanol-emollient antiseptic preparation with a conventional water-applied product. Am J Infect Control 2001; 29: Cimiotti JP, Marmur ES, Nesin M, Hamlin-Cook P, Larson EL. Adverse reactions associated with an alcohol-based hand antiseptic among nurses in a neonatal intensive care unit. Am J Infect Control 2003; 31: Kampf G, Rudolf M, Labadie JC, Barrett SP. Spectrum of antimicrobial activity and user acceptability of the hand disinfectant agent Sterillium Gel. J Hosp Infect 2002; 52: Kramer A, Bernig T, Kampf G. Clinical double-blind trial on the dermal tolerance and user acceptability of six alcohol-based hand disinfectants for hygienic hand. J Hosp Infect 2002; 51: Buxbaum A, Kratzer C, Graninger W, Georgopoulos A. Antimicrobial and toxicological profile of the new biocide Akacid Plus. J Antimicrob Chemother 2006; 58: Kratzer C, Tobudic S, Assadian O, Buxbaum A, Graninger W, Georgopoulos A. Validation of Akacid Plus as a room disinfectant in the hospital setting. Appl Environ Microbiol 2006; 72: Kratzer C, Tobudic S, Graninger W, Buxbaum A, Georgopoulos A. In vitro antimicrobial activity of the novel polymeric guanidine Akacid Plus. J Hosp Infect 2006; 63: Marchetti MG, Kampf G, Finzi G, Salvatorelli G. Evaluation of the bactericidal effect of five products for surgical hand according to pren and pren J Hosp Infect 2003; 54: Rotter ML, Kampf G, Suchomel M, Kundi M. Population kinetics of the skin flora on gloved hands following surgical hand with 3 propanol-based hand rubs: a prospective, randomized, double-blind trial. Infect Control Hosp Epidemiol 2007; 28: Nuutinen J, Alanen E, Autio P, Lahtinen MR, Harvima I, Lahtinen T. A closed unventilated chamber for the measurement of transepidermal water loss. Skin Res Technol 2003; 9: Alanen E, Nuutinen J, Nicklen K, Lahtinen T, Monkkonen J. Measurement of hydration in the stratum corneum with the MoistureMeter and comparison with the Corneometer. Skin Res Technol 2004; 10: Pessoa-Silva CL, Dharan S, Hugonnet S, et al. Dynamics of bacterial hand contamination during routine neonatal care. Infect Control Hosp Epidemiol 2004; 25: Kac G, Podglajen I, Gueneret M, Vaupre S, Bissery A, Meyer G. Microbiological evaluation of two hand hygiene procedures achieved by healthcare workers during routine patient care: a randomized study. J Hosp Infect 2005; 60: Sickbert-Bennett EE, Weber DJ, Gergen-Teague MF, Rutala WA. The effects of test variables on the efficacy of hand hygiene agents. Am J Infect Control 2004; 32:69 83.