Appendix 4Main Study Findings and Author’s Conclusions
Table A5Summary of Findings of Included Studies
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| Main Study Findings | Author’s Conclusion |
|---|
| Agthe 200915 |
|---|
Part 1 (no comparator product used)
CFUs recovered from hands of healthcare workers after the use of water based disinfectant, number of subjects(%)
First sampling Before disinfectant 0–10 CFUs: 32(50) 11–99 CFUs: 17(27) 100–199 CFUs: 11(17) ≥200 CFUs: 4(6)
After disinfectant 0–10 CFUs: 60(90) 11–99 CFUs: 3(4) 100–199 CFUs: 4(6) ≥200 CFUs: 0
Second sampling Before disinfectant 0–10 CFUs: 19(58) 11–99 CFUs: 7(21) 100–199 CFUs: 6(18) ≥200 CFUs: 1(3)
After disinfectant 0–10 CFUs: 29(88) 11–99 CFUs: 3(9) 100–199 CFUs: 1(3) ≥200 CFUs: 0
Third sampling Before disinfectant 0–10 CFUs: 23(55) 11–99 CFUs: 16(38) 100–199 CFUs: 3(7) ≥200 CFUs: 0
After disinfectant 0–10 CFUs: 43(93) 11–99 CFUs: 3(7) 100–199 CFUs: 0 ≥200 CFUs: 0
No statistically significant differences were observed for subjective assessments of dryness and eczema between the water-based (based on 174 observations) and alcohol-based (based on 43 observations) groups. Users of the water-based hand disinfectant reported drying and itching of the skin more often than the control subjects (39% vs 17%; P=0.019)
Part 2 (alcohol-based comparator product was used)
After 3 minutes of disinfection using the invitro EN12791 test procedure, the mean (±SD) log reduction factor in colony forming units for the water based group was 2.69 (±1.36) vs 3.18(±0.98) in the alcohol-based group. After 3 hours, the mean (±SD) log reduction factor in colony forming units for the water based group was 2.01 (±1.83) vs 2.59(±1.12) in the alcohol-based group.
| Part 1
Colonization of the fingertips was reduced based on the number of CFUs counted before disinfection compared to the number after disinfection (P<0.01). 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.
Part 2
The microbiological efficacy of the water-based hand disinfectant against bacteria was at least as good as that of alcohol-based hand disinfection product. When tested in accordance with the European standard, the product met the requirements for short term and long-term efficacy.
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| Nhung et al (2007)11 |
|---|
Part 1:
Immediate efficacy after 30 s hand rub on resident skin flora, N=5 (log10 values±SD),
* <0.05 compared to pre-values (t-test)
Aerobic bacteria Pre rub Post rub Pre minus Post
Anaerobic bacteria Pre rub 2-propanol 60%: 6.74±017 Nanochlorex: 6.67±0.13
Post rub Pre minus Post
Part2
Bacterial efficacy after 30 s hand rub on resident skin flora, N=8 (log10 values±SD)
* p<0.05 compared to pre-values (t-test)
** p<0.05 compared to Purell (t-test)
Ex vivo testing
An ex vivo test was used to study the rub activity against repeated contaminations of human skin by S. epidermidis. Human skin specimens initially treated by either the chlorhexidine product or the 62% ethanol gel for 5 min and then were artificially contaminated at time +5 min, +1 h, +2 h, and +3 h. A statistically significant difference in the log10 CFU/ml was confirmed between chlorhexidine and the 62% ethanol gel at 1 hour (P < 0.001), 2 hours (P < 0.001) and 3 hours (P < 0.01), favouring the chlorhexidine product. After the fourth contamination, no significant difference in antibacterial activity was shown between the products. | Part 1
Immediate efficacy on resident hand flora (N=5), Table 1: Nanochlorex and 2-propanol 60% reduced post-values of surviving aerobic bacteria on hands; Nanochlorex reduced bacteria by an average log10 reduction factor, which was not significantly different from 2-propanol 60% (0.30 versus 0.38). However, a 30-s hand rub with 2-propanol 60% (v/v) was not found effective against anaerobic bacteria, whereas Nanochlorex achieved the required efficacy.
Part 2
Immediate antibacterial efficacy of Nanochlorex was not significantly different from Purell. However, Purell was not found effective to insure a significant decrease of bacterial post-values at 3 h. Sustained efficacy of Nanochlorex was shown against bacteria as evidenced by the comparable average log10 reduction factors determined at 30 s and 3 h.
Overall
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CFU= colony forming unit; h=hours; RF=reduction factor; s=seconds; SD= standard deviation; v/v= volume/volume
Table A6Summary of Evidence-based Guidelines
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| Guideline | Selected Recommendations |
|---|
| Public Health Ontario: Best Practices for Hand Hygiene in All Healthcare Settings (2014)3 | There is no evidence for the efficacy of non-alcoholic, waterless antiseptic agents in the health care environment. Non-alcoholic products have a quaternary ammonium compound (QAC) as the active ingredient, which has not been shown to be as effective against most microorganisms as ABHR or soap and water. QACs are prone to contamination by Gram-negative organisms. QACs are also associated with an increase in skin irritancy.
Non-alcohol-based waterless antiseptic agents are not recommended for hand hygiene in health care settings and should not be used.
Use 70 to 90% alcohol-based hand rub for hand hygiene in all health care settings. Wash hands with soap and water if there is visible soiling with dirt, blood, body fluids or other body substances. If hands are visibly soiled and running water is not available, use moistened towelettes to remove the visible soil, followed by alcohol-based hand rub. In all health care settings, provide hand hygiene products at point-of-care for use by staff and clients/patients/residents. Dispense all hand hygiene and hand care products from a disposable dispenser that delivers an appropriate volume of the product. Use single-use product dispensers that are discarded when empty. Do not “top-up” or refill containers. Clearly define responsibility for maintaining product dispensers. Do not use bar soap for hand hygiene in any health care settings except for individual client/patient/resident use. Do not use alcohol-free, waterless antiseptic agents as hand hygiene agents in any health care setting. Consider user acceptability as a factor in hand hygiene product selection. Choose hand hygiene and hand care products with low irritant potential. Hand hygiene products must not interfere with glove integrity or with the action of other hand hygiene or hand care products. Evaluate the dispenser system of product manufacturers to ensure that dispensers function adequately and deliver an appropriate volume of product.
(Source: pg 23) |
| NICE: Surgical site infection prevention and treatment of surgical site infection (2008)5,6 | Hands must be decontaminated immediately before every episode of direct patient contact/care and after any activity or contact that potentially results in hands becoming contaminated. Hands that are visibly soiled or potentially grossly contaminated with dirt or organic material must be washed with liquid soap and water. Hands should be decontaminated between caring for different patients or between different care activities for the same patient, including after removal of gloves. For convenience and efficacy, an alcohol-based hand rub is preferable unless hands are visibly soiled.
(Source: Appendix H) |
| PHAC Hand Hygiene Practices in Healthcare Settings (2012)2 | 1.1. Alcohol-based hand rub is the preferred method of hand hygiene in all healthcare settings with the exceptions outlined in Part D, Section 1.2.
1.2. Hand hygiene using soap and water, instead of alcohol-based hand rubs, should be performed as follows:
1.2.1. To remove visible soil and/or organic material
1.2.2. When a buildup of alcohol-based hand rub product feels uncomfortable on the hands after multiple applications. (Note: alcohol-based hand rub remains effective in this situation). Manufacturer’s recommendation
1.2.3. At the point-of-care after caring for a patient with norovirus or C. difficile infection. If a designated handwashing sink is not available at the point-of-care, alcohol-based hand rub should be used and hands should be washed with soap and water as soon as a suitable handwash sink is available. (Note: Patients with norovirus or C. difficile infection are on contact precautions. This includes wearing gloves for the care of the patient and/or contact with the patient environment. Hand hygiene with soap and water should be performed following the removal of gloves at the point-of-care).
1.2.4. During outbreaks or in settings with high transmission of norovirus or C. difficile infection
1.2.5. With suspected or documented exposure to B. anthracis-contaminated items.
1.2.6. Immediately after using toilet facilities
1.3. Hand hygiene should be performed with alcohol-based hand rub preferably at the point-of-care in all healthcare settings
1.4. Alcohol-based hand rubs with an alcohol (i.e., ethanol, isopropanol or n propanol) concentration above 60% and up to 90% should be used for clinical care
1.4.1. Alcohol concentrations above 80% may be necessary for gels
1.4.2. Alcohol concentrations with a minimum of 70% should be considered during outbreaks or in settings with a high transmission of norovirus
1.4.3. Hand rubs that contain either no alcohol or alcohol in concentrations lower than 60% for hand hygiene should not be used.
1.4.4. Hand hygiene products purchased for use in Canadian healthcare settings should be approved for professional use and have either a Health Canada Natural Product Number or a Drug Identification Number.
(Source: Part D) |
| WHO Guidelines on Hand Hygiene in Health Care (2009)4 | A. Wash hands with soap and water when visibly dirty or visibly soiled with blood or other body fluids or after using the toilet
B. If exposure to potential spore-forming pathogens is strongly suspected or proven, including outbreaks of Clostridium difficile, hand washing with soap and water is the preferred means
C. Use an alcohol-based hand rub as the preferred means for routine hand antisepsis in all other clinical situations described in items D(a) to D(f) listed below, if hands are not visibly soiled If alcohol-based hand rub is not obtainable, wash hands with soap and water
D. Perform hand hygiene:
a. before and after touching the patient
b. before handling an invasive device for patient care regardless of whether or not gloves are used (IB);
c. after contact with body fluids or excretions, mucous membranes, non-intact skin, or wound dressings
d. if moving from a contaminated body site to another body site during care of the same patient
e. after contact with inanimate surfaces and objects (including medical equipment) in the immediate vicinity of the patient
f. after removing sterile or non-sterile gloves
(Source: pg 152) |
