- Email: [email protected]
Suitability of Sterillium Gel™ for surgical hand disinfection
Journal of Hospital Infection (2003) 54, 222–225
www.elsevierhealth.com/journals/jhin
Suitability of Sterillium Gele for surgical hand disinfection G. Kampfa,*, M. Kapellab a
Bode Chemie GmbH & Co., Scientific Affairs, Hamburg, Germany; and Asklepios Klinik Birkenwerder, Birkenwerder, Germany
b
Received 15 November 2002; accepted 12 February 2003
KEYWORDS Alcohol-based hand gel; Surgical hand disinfection; Sterillium Gele; prEN 12791
Summary In some countries, alcohol-based hand gels are used for hygienic hand disinfection but their efficacy and suitability for surgical hand disinfection has never been investigated. The efficacy of Sterillium Gele was investigated according to prEN 12791 in two separate experiments. Finger tips of 20 volunteers per experiment were sampled for resident skin bacteria before surgical hand disinfection. In a cross-over design, each volunteer carried out a surgical hand disinfection with the reference alcohol [n-propanol 60%, (v/v)] or Sterillium Gele [ethanol 85% (v/v)] for 3 min. After the product application, one hand was sampled for the immediate effect, the other hand was gloved for 3 h and then sampled for the sustained effect. Samples were analysed for remaining resident bacteria. The mean of the pre-value, the 0 h and 3 h values of the reference disinfection and the test product were calculated. With the reference alcohol, respective mean immediate log10-reduction factors of 2.06 ^ 0.76 and 2.23 ^ 1.13 were found in both experiments. The mean sustained effects with the reference alcohol were 2.03 ^ 1.14 and 1.44 ^ 0.81. Sterillium Gele achieved respective mean immediate effects of 2.48 ^ 1.06 and 2.13 ^ 0.81, the mean sustained effects were 2.77 ^ 0.95 and 2.18 ^ 0.72. They proved significantly larger than those obtained with the reference alcohol (P , 0:05; pair-wise Wilcoxon test). Sterillium Gele, therefore, more than fulfils the efficacy requirements for surgical hand disinfection of prEN 12791. In addition, 25 of 26 operating theatre healthcare workers in an orthopaedic hospital found it suitable for surgical hand disinfection after a single use, which included putting on a pair of surgical gloves. Although none of them had ever used an alcohol-based gel before, they had rather been accustomed to alcohol-based liquid products for years. The main reasons given for the positive assessment were better skin feeling after use, smell and easier donning of the surgical gloves. No significant correlation was found between overall or dermal acceptance and years of professional experience, profession or number of gel portions used for surgical hand disinfection (Pearson’s correlation; P . 0:05). Q 2003 The Hospital Infection Society. Published by Elsevier Science Ltd. All rights reserved.
Introduction *Corresponding author. Tel.: þ 49-40-540060; fax: þ 49-4054006-128. E-mail address: [email protected]
Alcohol-based liquid rubs have been used in Europe for the preoperative treatment of hands for decades. The main reason for the use of alcohols
0195-6701/03/$ - see front matter Q 2003 The Hospital Infection Society. Published by Elsevier Science Ltd. All rights reserved. doi:10.1016/S0195-6701(03)00087-2
Suitability of Sterillium gele for hand disinfection
is their better antimicrobial efficacy compared with preparations based on other active ingredients such as chlorhexidine.1 In addition alcohol-based liquid rubs are better tolerated by the healthcare workers’ skin.2,3 Recently alcohol-based hand gels have been introduced in some countries, mainly for hygienic hand disinfection.4 Most of them have been described as significantly less effective than liquid products.5 That is why the use of most alcohol-based hand gels in healthcare settings has generally been viewed unfavourably.5 So far, only one ethanol-based hand gel (Sterillium Gele) has been found effective for hygienic hand disinfection within 30 s.6 In a new European recommendation on surgical hand disinfection prepared by representatives of various infection control societies, it has been proposed that an alcohol-based hand gel shall not be used unless it meets the requirements of prEN 12791 with respect to the antimicrobial efficacy.7 Furthermore, user acceptability is an important focus of research.6 To date, an alcohol-based hand gel has never been assessed by surgical staff of an operating theatre to the best of our knowledge. The aim of this study was to evaluate the suitability of Sterillium Gele for surgical hand disinfection.
Method Surgical hand disinfection according to prEN 12791 Twenty participants were included for each of two experiments. Hands were pre-washed with soap for 1 min. Initial bacterial counts were obtained by rubbing finger tips in tryptic soy broth (TSB) for 1 min. Afterwards, each participant treated their hands with the reference product (n-propanol, 60%) or the product. For the reference disinfection, n-propanol was applied in three to four applications in order to keep the skin moist for a total of 3 min. Sterillium Gele based on 85% (w/w) ethanol was also applied in three to four portions in order to keep the skin moist for a total of 3 min. Subsequent bacterial counts (immediate effect) were taken from one hand by rubbing finger tips in TSB containing neutralizers for 1 min; the other hand was gloved for 3 h. After gloves were taken off, final bacterial counts were taken by rubbing finger tips in TSB for 1 min (sustained effect). The bacterial concentration in the sampling fluid was determined by serial dilution and surface culture. The differences between the log10 pre- and post-treatment values were calculated individually for each subject.8 Means of these differences were analysed with the Wilcoxon matched-pairs signed-ranks test.9
223
User acceptability Sixteen orthopaedic surgeons and 10 theatre nurses were asked to assess the suitability of Sterillium Gele for its use as a surgical hand disinfectant. All of them were accustomed to liquid alcohol-based rubs for surgical hand disinfection. They applied the gel for a period of 3 min with as many applications as necessary to keep the skin moist with a layer of the gel, similar to a standard surgical hand disinfection. After disinfection, hands were air dried before surgical gloves were donned. Each healthcare worker was then asked to assess the gel by answering the following questions: † For how many years have you been using alcoholbased liquid rubs for surgical hand disinfection? (open question) † What is your professional status? (medical doctor, nursing staff) † Have you ever used an alcohol-based hand gel before for surgical hand disinfection? (yes, no) † How do you rate surgical hand disinfection with the gel as compared with the liquid product which is used regularly? (better, equal, worse) † How did the skin feel after taking off the surgical glove as compared with the lipid product which is used regularly? (better, equal, worse) † What are the main reasons for your assessment? (open question) † Do you consider a gel to be suitable for surgical hand disinfection? (yes, no) † What are the main reasons for your final assessment? (open question)
Results Efficacy according to prEN 12791 In two separate experiments with 20 volunteers Sterillium Gele was found to be equally effective (immediate effect) or more effective (sustained effect) than the reference alcohol (Table I). After 3 h the difference was statistically significant in both experiments ðP , 0:05Þ: Sterillium Gele can therefore be considered to have a sustained effect.
User acceptability Twenty-six healthcare workers used the gel for surgical hand disinfection. Sixteen of them were medical doctors (62%) and 10 were theatre nurses (38%). All participants were used to an alcoholbased liquid rub for surgical hand disinfection with a professional experience of 11 ^ 7 years. None of
224
G. Kampf, M. Kapella
Table I Bactericidal efficacy of Sterillium Gele (3 min) in comparison with the reference alcohol (60% n-propanol; 3 min) for surgical hand disinfection according to prEN 12791 Experiment 1
Reference alcohol Sterillium Gele P-value
Experiment 2
Immediate effect
Sustained effect
Immediate effect
Sustained effect
2.06 ^ 0.76 2.48 ^ 1.06 0.167
2.03 ^ 1.14 2.77 ^ 0.95 0.04
2.23 ^ 1.13 2.13 ^ 0.18 0.81
1.44 ^ 0.81 2.18 ^ 0.72 0.008
P-values were obtained by the matched-pairs signed-ranks test of Wilcoxon.
them hand ever used an alcohol-based hand gel before for preoperative treatment of hands. Overall, 92% assessed the gel to be better or equal in comparison with the alcohol-based liquid rubs, only 8% regarded the gel to be worse. Skin feeling was found to be better or equal in 77%, 23% thought the gel was worse. (Table II). The main reasons for the general positive assessment were the skin feeling (‘the skin feels like treated with a cream’; 50%), the smell (50%) and the easy glide into the surgical glove (35%). The worse assessment was mainly explained with tackiness (23%), a crumbly feeling (15%) or the feeling of an oily film on the skin (15%). None of the healthcare workers described it as more difficult to glide into the surgical gloves after using the gel (Table III). Further analysis revealed no significant correlation between the general or the dermal acceptance and the years of professional experience, the professional status or the number of gel portions used for surgical hand disinfection (Pearson’s correlation; P . 0:05). Overall, 25 of 26 healthcare workers thought that the gel was suitable for surgical hand disinfection.
Discussion Sterillium Gele was found to meet the requirements for bactericidal efficacy for a surgical hand rub and is, according to our knowledge, the first alcohol-based hand gel in literature to have repeatedly passed this efficacy requirement. After Table II Assessment of Sterillium Gele after a single surgical hand disinfection in comparison with the alcoholbased liquid rubs that had been used regularly by 26 theatre staff of an orthopaedic hospital Type of assessment
Better
Equal
Worse
Overall Dermal
13 (50%) 17 (65%)
11 (42%) 3 (12%)
2 (8%) 6 (23%)
Dermal assessment was done after taking off the surgical gloves which were worn for 1 min after the surgical hand disinfection.
3 h (gloved hand), it was significantly more effective than the reference alcohol and can therefore be regarded as having a sustained effect. The sustained effect may be explained by a strong immediate bactericidal activity which allows little recovery of the resident skin flora. The effect may in addition be due to the ethanol itself which has been shown marginally to damage bacteria. These bacteria may well recover with immediate inoculation on to culture media but not if left on the skin for 3 h before inoculation on to the medium.10 From the efficacy point of view, the gel can therefore be considered suitable for surgical hand disinfection based on prEN 12791, which has been described to lead to accurate results.11 In addition, Sterillium Gele was shown to be free of any risk of irritation or sensitization, even under occlusive test conditions.12 In the second part of the study, 25 of 26 healthcare workers of a surgical team assessed the gel to be suitable for surgical hand disinfection although none had ever used an alcohol-based hand gel before. Half thought that the gel was better than the alcohol-based liquid rubs routinely used every day, mainly among the nursing staff. The main reason for this appeared to be the positive skin feeling. This is particularly important among healthcare workers with long professional experience who Table III Summary of free comments from 26 healthcare workers on the advantages and disadvantages of Sterillium Gele for surgical hand disinfection Type of comment
Frequency
The skin feels like treated with a cream Good smell Easy glide into the surgical glove Quick absorption into the skin Tacky skin The skin feels soft Crumbly skin feeling Oily skin feeling No splashes on floor Economic use Refreshing to skin Slow absorption into the skin
13 (50%) 13 (50%) 9 (35%) 6 (23%) 6 (23%) 5 (19%) 4 (15%) 4 (15%) 3 (12%) 2 (8%) 1 (4%) 1 (4%)
Suitability of Sterillium gele for hand disinfection
may suffer from dry skin. Another positive factor was the smell of the gel, which supports the findings of a previous study.6 For surgical hand disinfection, the long application time of 3 min results in a higher impact of the smell in the overall assessment by the user. Whilst the gel is generally attractive for surgical hand disinfection, other relevant issues should considered. All gels have a thickening system which is not volatile and which will remain on the skin and accumulate. Some healthcare workers noticed this in our study as well (tackiness, crumbly skin feeling). For hygienic hand disinfection accumulation has been assessed for Sterillium Gele by healthcare workers in the wards and mainly found to be good or acceptable.6 Nevertheless, some gels aggregate more quickly and lead to even more crumbly feeling and deposit a thin layer on the skin. Tackiness has been reported for another gel resulting in a relatively negative assessment by healthcare workers.13 This tackiness can make it difficult for surgeons to get their hands into surgical gloves. This was not the case with Sterillium Gele where healthcare workers found the opposite: 35% thought that the gel made it easier to don surgical gloves. One limitation of our study was the single use. With repeated surgical hand disinfections and without washing the hands in between, the thickening system on the skin will increase. The surgeon may then feel the need to wash the hands after taking off the gloves. Handwashing as a part of the surgical hand disinfection is, however, no longer recommended because the handwash may impair the efficacy of the consecutive hand rub and promote skin dryness and dermal irritation.7 In comparison with liquids, which have essentially no aggregation of nonvolatile compounds on to the skin, alcohol-based hand gels for surgical hand disinfection may, therefore, have this disadvantage. Another limitation of our study is the short duration of wearing gloves: 1 min in our study was chosen because it is easy to perform and it provides a first user assessment without a huge time commitment. We do not know therefore what the dermal assessment would be if gloves were worn for 3 h. Although Sterillium Gele is known to have an excellent dermal tolerance under occlusive test conditions,12 future research will need to show whether tolerance changes under the surgical glove during an operation. In conclusion, Sterillium Gele was found effective
225
for the preoperative treatment of hands. The acceptance by operating staff was positive. In general, it seems advisable to test new alcoholbased hand gels for suitability both in terms of efficacy according to prEN 12791 and in terms of the acceptability among the actual users. In this respect, our study is the first of its kind. In addition, Sterillium Gele is currently, to our knowledge, the only alcoholbased hand gel to fulfil the efficacy requirement of prEN 12791. Further experience will show if alcoholbased gels will find their place in the surgical theatre.
References 1. Rotter ML. Arguments for the alcoholic hand disinfection. J Hosp Infect 2001;48:S4—S8. 2. Girard R, Re ´at C, Carboni N, Bouket J-L. L’antisepsie chirurgicale des mains peut-elle remplacer en routine le lavage chirurgical des mains? Eassai en bloc d’orthope ´die `neS 1996;12:34—38. re ´gle ´e. Hygie 3. Winnefeld M, Richard MA, Drancourt M, Grobb JJ. Skin tolerance and effectiveness of two hand decontamination procedures in everyday hospital use. Br J Dermatol 2000; 143:546—550. 4. Pietsch H. Hand antiseptics: rubs versus scrubs, alcoholic solutions versus alcoholic gels. J Hosp Infect 2001;48: S33—S36. 5. Kramer A, Rudolph P, Kampf G, Pittet D. Limited efficacy of alcohol-based hand gels. Lancet 2002;359:1489—1490. 6. Kampf G, Rudolf M, Labadie J-C, Barrett S. Spectrum of antimicrobial activity and user acceptability of the hand disinfectant agent Sterillium Gel. J Hosp Infect 2002;52: 141—147. 7. Labadie J-C, Kampf G, Lejeune B, et al. Recommendation for surgical hand disinfection-requirements, implementation and need for research. A proposal by representatives of the SFHH, DGHM, DGKH for a European discussion. J Hosp Infect 2002;51:312—315. 8. prEN 12791. Chemische Desinfektionsmittel und Antiseptika. Chirurgische Ha ¨ndedesinfektionsmittel—Pru ¨fverfahren und Anforderungen (Phase 2/Stufe 2). 1997. 9. Altman DG. Practical statistics for medical research, 1st edn. London: Chapman & Hall; 1991. 10. Lowbury EJL, Lilly HA, Ayliffe GAJ. Preoperative disinfections of surgeons’ hands: use of alcoholic solutions and effects of gloves on skin flora. Br Med J 1974;4:369—372. 11. Rotter ML, Simpson RA, Koller W. Surgical hand disinfection with alcohols at various concentrations: parallel experiments using the new proposed European standards methods. Infect Control Hosp Epidemiol 1998;19:778—781. 12. Kampf G, Muscatiello M, Ha ¨ntschel D, Rudolf M. Dermal tolerance and skin hydration properties of a new ethanolbased hand gel. J Hosp Infect 2002;52:297—301. 13. Harbarth S, Pittet D, Grady L, et al. Interventional study to evaluate the impact of an alcohol-based hand gel in improving hand hygiene compliance. Pediatr Infect Dis J 2002;21:489—495.
www.elsevierhealth.com/journals/jhin
Suitability of Sterillium Gele for surgical hand disinfection G. Kampfa,*, M. Kapellab a
Bode Chemie GmbH & Co., Scientific Affairs, Hamburg, Germany; and Asklepios Klinik Birkenwerder, Birkenwerder, Germany
b
Received 15 November 2002; accepted 12 February 2003
KEYWORDS Alcohol-based hand gel; Surgical hand disinfection; Sterillium Gele; prEN 12791
Summary In some countries, alcohol-based hand gels are used for hygienic hand disinfection but their efficacy and suitability for surgical hand disinfection has never been investigated. The efficacy of Sterillium Gele was investigated according to prEN 12791 in two separate experiments. Finger tips of 20 volunteers per experiment were sampled for resident skin bacteria before surgical hand disinfection. In a cross-over design, each volunteer carried out a surgical hand disinfection with the reference alcohol [n-propanol 60%, (v/v)] or Sterillium Gele [ethanol 85% (v/v)] for 3 min. After the product application, one hand was sampled for the immediate effect, the other hand was gloved for 3 h and then sampled for the sustained effect. Samples were analysed for remaining resident bacteria. The mean of the pre-value, the 0 h and 3 h values of the reference disinfection and the test product were calculated. With the reference alcohol, respective mean immediate log10-reduction factors of 2.06 ^ 0.76 and 2.23 ^ 1.13 were found in both experiments. The mean sustained effects with the reference alcohol were 2.03 ^ 1.14 and 1.44 ^ 0.81. Sterillium Gele achieved respective mean immediate effects of 2.48 ^ 1.06 and 2.13 ^ 0.81, the mean sustained effects were 2.77 ^ 0.95 and 2.18 ^ 0.72. They proved significantly larger than those obtained with the reference alcohol (P , 0:05; pair-wise Wilcoxon test). Sterillium Gele, therefore, more than fulfils the efficacy requirements for surgical hand disinfection of prEN 12791. In addition, 25 of 26 operating theatre healthcare workers in an orthopaedic hospital found it suitable for surgical hand disinfection after a single use, which included putting on a pair of surgical gloves. Although none of them had ever used an alcohol-based gel before, they had rather been accustomed to alcohol-based liquid products for years. The main reasons given for the positive assessment were better skin feeling after use, smell and easier donning of the surgical gloves. No significant correlation was found between overall or dermal acceptance and years of professional experience, profession or number of gel portions used for surgical hand disinfection (Pearson’s correlation; P . 0:05). Q 2003 The Hospital Infection Society. Published by Elsevier Science Ltd. All rights reserved.
Introduction *Corresponding author. Tel.: þ 49-40-540060; fax: þ 49-4054006-128. E-mail address: [email protected]
Alcohol-based liquid rubs have been used in Europe for the preoperative treatment of hands for decades. The main reason for the use of alcohols
0195-6701/03/$ - see front matter Q 2003 The Hospital Infection Society. Published by Elsevier Science Ltd. All rights reserved. doi:10.1016/S0195-6701(03)00087-2
Suitability of Sterillium gele for hand disinfection
is their better antimicrobial efficacy compared with preparations based on other active ingredients such as chlorhexidine.1 In addition alcohol-based liquid rubs are better tolerated by the healthcare workers’ skin.2,3 Recently alcohol-based hand gels have been introduced in some countries, mainly for hygienic hand disinfection.4 Most of them have been described as significantly less effective than liquid products.5 That is why the use of most alcohol-based hand gels in healthcare settings has generally been viewed unfavourably.5 So far, only one ethanol-based hand gel (Sterillium Gele) has been found effective for hygienic hand disinfection within 30 s.6 In a new European recommendation on surgical hand disinfection prepared by representatives of various infection control societies, it has been proposed that an alcohol-based hand gel shall not be used unless it meets the requirements of prEN 12791 with respect to the antimicrobial efficacy.7 Furthermore, user acceptability is an important focus of research.6 To date, an alcohol-based hand gel has never been assessed by surgical staff of an operating theatre to the best of our knowledge. The aim of this study was to evaluate the suitability of Sterillium Gele for surgical hand disinfection.
Method Surgical hand disinfection according to prEN 12791 Twenty participants were included for each of two experiments. Hands were pre-washed with soap for 1 min. Initial bacterial counts were obtained by rubbing finger tips in tryptic soy broth (TSB) for 1 min. Afterwards, each participant treated their hands with the reference product (n-propanol, 60%) or the product. For the reference disinfection, n-propanol was applied in three to four applications in order to keep the skin moist for a total of 3 min. Sterillium Gele based on 85% (w/w) ethanol was also applied in three to four portions in order to keep the skin moist for a total of 3 min. Subsequent bacterial counts (immediate effect) were taken from one hand by rubbing finger tips in TSB containing neutralizers for 1 min; the other hand was gloved for 3 h. After gloves were taken off, final bacterial counts were taken by rubbing finger tips in TSB for 1 min (sustained effect). The bacterial concentration in the sampling fluid was determined by serial dilution and surface culture. The differences between the log10 pre- and post-treatment values were calculated individually for each subject.8 Means of these differences were analysed with the Wilcoxon matched-pairs signed-ranks test.9
223
User acceptability Sixteen orthopaedic surgeons and 10 theatre nurses were asked to assess the suitability of Sterillium Gele for its use as a surgical hand disinfectant. All of them were accustomed to liquid alcohol-based rubs for surgical hand disinfection. They applied the gel for a period of 3 min with as many applications as necessary to keep the skin moist with a layer of the gel, similar to a standard surgical hand disinfection. After disinfection, hands were air dried before surgical gloves were donned. Each healthcare worker was then asked to assess the gel by answering the following questions: † For how many years have you been using alcoholbased liquid rubs for surgical hand disinfection? (open question) † What is your professional status? (medical doctor, nursing staff) † Have you ever used an alcohol-based hand gel before for surgical hand disinfection? (yes, no) † How do you rate surgical hand disinfection with the gel as compared with the liquid product which is used regularly? (better, equal, worse) † How did the skin feel after taking off the surgical glove as compared with the lipid product which is used regularly? (better, equal, worse) † What are the main reasons for your assessment? (open question) † Do you consider a gel to be suitable for surgical hand disinfection? (yes, no) † What are the main reasons for your final assessment? (open question)
Results Efficacy according to prEN 12791 In two separate experiments with 20 volunteers Sterillium Gele was found to be equally effective (immediate effect) or more effective (sustained effect) than the reference alcohol (Table I). After 3 h the difference was statistically significant in both experiments ðP , 0:05Þ: Sterillium Gele can therefore be considered to have a sustained effect.
User acceptability Twenty-six healthcare workers used the gel for surgical hand disinfection. Sixteen of them were medical doctors (62%) and 10 were theatre nurses (38%). All participants were used to an alcoholbased liquid rub for surgical hand disinfection with a professional experience of 11 ^ 7 years. None of
224
G. Kampf, M. Kapella
Table I Bactericidal efficacy of Sterillium Gele (3 min) in comparison with the reference alcohol (60% n-propanol; 3 min) for surgical hand disinfection according to prEN 12791 Experiment 1
Reference alcohol Sterillium Gele P-value
Experiment 2
Immediate effect
Sustained effect
Immediate effect
Sustained effect
2.06 ^ 0.76 2.48 ^ 1.06 0.167
2.03 ^ 1.14 2.77 ^ 0.95 0.04
2.23 ^ 1.13 2.13 ^ 0.18 0.81
1.44 ^ 0.81 2.18 ^ 0.72 0.008
P-values were obtained by the matched-pairs signed-ranks test of Wilcoxon.
them hand ever used an alcohol-based hand gel before for preoperative treatment of hands. Overall, 92% assessed the gel to be better or equal in comparison with the alcohol-based liquid rubs, only 8% regarded the gel to be worse. Skin feeling was found to be better or equal in 77%, 23% thought the gel was worse. (Table II). The main reasons for the general positive assessment were the skin feeling (‘the skin feels like treated with a cream’; 50%), the smell (50%) and the easy glide into the surgical glove (35%). The worse assessment was mainly explained with tackiness (23%), a crumbly feeling (15%) or the feeling of an oily film on the skin (15%). None of the healthcare workers described it as more difficult to glide into the surgical gloves after using the gel (Table III). Further analysis revealed no significant correlation between the general or the dermal acceptance and the years of professional experience, the professional status or the number of gel portions used for surgical hand disinfection (Pearson’s correlation; P . 0:05). Overall, 25 of 26 healthcare workers thought that the gel was suitable for surgical hand disinfection.
Discussion Sterillium Gele was found to meet the requirements for bactericidal efficacy for a surgical hand rub and is, according to our knowledge, the first alcohol-based hand gel in literature to have repeatedly passed this efficacy requirement. After Table II Assessment of Sterillium Gele after a single surgical hand disinfection in comparison with the alcoholbased liquid rubs that had been used regularly by 26 theatre staff of an orthopaedic hospital Type of assessment
Better
Equal
Worse
Overall Dermal
13 (50%) 17 (65%)
11 (42%) 3 (12%)
2 (8%) 6 (23%)
Dermal assessment was done after taking off the surgical gloves which were worn for 1 min after the surgical hand disinfection.
3 h (gloved hand), it was significantly more effective than the reference alcohol and can therefore be regarded as having a sustained effect. The sustained effect may be explained by a strong immediate bactericidal activity which allows little recovery of the resident skin flora. The effect may in addition be due to the ethanol itself which has been shown marginally to damage bacteria. These bacteria may well recover with immediate inoculation on to culture media but not if left on the skin for 3 h before inoculation on to the medium.10 From the efficacy point of view, the gel can therefore be considered suitable for surgical hand disinfection based on prEN 12791, which has been described to lead to accurate results.11 In addition, Sterillium Gele was shown to be free of any risk of irritation or sensitization, even under occlusive test conditions.12 In the second part of the study, 25 of 26 healthcare workers of a surgical team assessed the gel to be suitable for surgical hand disinfection although none had ever used an alcohol-based hand gel before. Half thought that the gel was better than the alcohol-based liquid rubs routinely used every day, mainly among the nursing staff. The main reason for this appeared to be the positive skin feeling. This is particularly important among healthcare workers with long professional experience who Table III Summary of free comments from 26 healthcare workers on the advantages and disadvantages of Sterillium Gele for surgical hand disinfection Type of comment
Frequency
The skin feels like treated with a cream Good smell Easy glide into the surgical glove Quick absorption into the skin Tacky skin The skin feels soft Crumbly skin feeling Oily skin feeling No splashes on floor Economic use Refreshing to skin Slow absorption into the skin
13 (50%) 13 (50%) 9 (35%) 6 (23%) 6 (23%) 5 (19%) 4 (15%) 4 (15%) 3 (12%) 2 (8%) 1 (4%) 1 (4%)
Suitability of Sterillium gele for hand disinfection
may suffer from dry skin. Another positive factor was the smell of the gel, which supports the findings of a previous study.6 For surgical hand disinfection, the long application time of 3 min results in a higher impact of the smell in the overall assessment by the user. Whilst the gel is generally attractive for surgical hand disinfection, other relevant issues should considered. All gels have a thickening system which is not volatile and which will remain on the skin and accumulate. Some healthcare workers noticed this in our study as well (tackiness, crumbly skin feeling). For hygienic hand disinfection accumulation has been assessed for Sterillium Gele by healthcare workers in the wards and mainly found to be good or acceptable.6 Nevertheless, some gels aggregate more quickly and lead to even more crumbly feeling and deposit a thin layer on the skin. Tackiness has been reported for another gel resulting in a relatively negative assessment by healthcare workers.13 This tackiness can make it difficult for surgeons to get their hands into surgical gloves. This was not the case with Sterillium Gele where healthcare workers found the opposite: 35% thought that the gel made it easier to don surgical gloves. One limitation of our study was the single use. With repeated surgical hand disinfections and without washing the hands in between, the thickening system on the skin will increase. The surgeon may then feel the need to wash the hands after taking off the gloves. Handwashing as a part of the surgical hand disinfection is, however, no longer recommended because the handwash may impair the efficacy of the consecutive hand rub and promote skin dryness and dermal irritation.7 In comparison with liquids, which have essentially no aggregation of nonvolatile compounds on to the skin, alcohol-based hand gels for surgical hand disinfection may, therefore, have this disadvantage. Another limitation of our study is the short duration of wearing gloves: 1 min in our study was chosen because it is easy to perform and it provides a first user assessment without a huge time commitment. We do not know therefore what the dermal assessment would be if gloves were worn for 3 h. Although Sterillium Gele is known to have an excellent dermal tolerance under occlusive test conditions,12 future research will need to show whether tolerance changes under the surgical glove during an operation. In conclusion, Sterillium Gele was found effective
225
for the preoperative treatment of hands. The acceptance by operating staff was positive. In general, it seems advisable to test new alcoholbased hand gels for suitability both in terms of efficacy according to prEN 12791 and in terms of the acceptability among the actual users. In this respect, our study is the first of its kind. In addition, Sterillium Gele is currently, to our knowledge, the only alcoholbased hand gel to fulfil the efficacy requirement of prEN 12791. Further experience will show if alcoholbased gels will find their place in the surgical theatre.
References 1. Rotter ML. Arguments for the alcoholic hand disinfection. J Hosp Infect 2001;48:S4—S8. 2. Girard R, Re ´at C, Carboni N, Bouket J-L. L’antisepsie chirurgicale des mains peut-elle remplacer en routine le lavage chirurgical des mains? Eassai en bloc d’orthope ´die `neS 1996;12:34—38. re ´gle ´e. Hygie 3. Winnefeld M, Richard MA, Drancourt M, Grobb JJ. Skin tolerance and effectiveness of two hand decontamination procedures in everyday hospital use. Br J Dermatol 2000; 143:546—550. 4. Pietsch H. Hand antiseptics: rubs versus scrubs, alcoholic solutions versus alcoholic gels. J Hosp Infect 2001;48: S33—S36. 5. Kramer A, Rudolph P, Kampf G, Pittet D. Limited efficacy of alcohol-based hand gels. Lancet 2002;359:1489—1490. 6. Kampf G, Rudolf M, Labadie J-C, Barrett S. Spectrum of antimicrobial activity and user acceptability of the hand disinfectant agent Sterillium Gel. J Hosp Infect 2002;52: 141—147. 7. Labadie J-C, Kampf G, Lejeune B, et al. Recommendation for surgical hand disinfection-requirements, implementation and need for research. A proposal by representatives of the SFHH, DGHM, DGKH for a European discussion. J Hosp Infect 2002;51:312—315. 8. prEN 12791. Chemische Desinfektionsmittel und Antiseptika. Chirurgische Ha ¨ndedesinfektionsmittel—Pru ¨fverfahren und Anforderungen (Phase 2/Stufe 2). 1997. 9. Altman DG. Practical statistics for medical research, 1st edn. London: Chapman & Hall; 1991. 10. Lowbury EJL, Lilly HA, Ayliffe GAJ. Preoperative disinfections of surgeons’ hands: use of alcoholic solutions and effects of gloves on skin flora. Br Med J 1974;4:369—372. 11. Rotter ML, Simpson RA, Koller W. Surgical hand disinfection with alcohols at various concentrations: parallel experiments using the new proposed European standards methods. Infect Control Hosp Epidemiol 1998;19:778—781. 12. Kampf G, Muscatiello M, Ha ¨ntschel D, Rudolf M. Dermal tolerance and skin hydration properties of a new ethanolbased hand gel. J Hosp Infect 2002;52:297—301. 13. Harbarth S, Pittet D, Grady L, et al. Interventional study to evaluate the impact of an alcohol-based hand gel in improving hand hygiene compliance. Pediatr Infect Dis J 2002;21:489—495.