a better disinfectant for low resourced hospitals a multi period cluster randomised CORD-Papers-2022-06-02 (Version 1)

Title: A Better Disinfectant for Low-Resourced Hospitals? A Multi-Period Cluster Randomised Trial Comparing Hypochlorous Acid with Sodium Hypochlorite in Nigerian Hospitals: The EWASH Trial
Abstract: Environmental hygiene in hospitals is a major challenge worldwide. Low-resourced hospitals in African countries continue to rely on sodium hypochlorite (NaOCl) as major disinfectant. However NaOCl has several limitations such as the need for daily dilution irritation and corrosion. Hypochlorous acid (HOCl) is an innovative surface disinfectant produced by saline electrolysis with a much higher safety profile. We assessed non-inferiority of HOCl against standard NaOCl for surface disinfection in two hospitals in Abuja Nigeria using a double-blind multi-period randomised cross-over study. Microbiological cleanliness [Aerobic Colony Counts (ACC)] was measured using dipslides. We aggregated data at the cluster-period level and fitted a linear regression. Microbiological cleanliness was high for both disinfectant (84.8% HOCl; 87.3% NaOCl). No evidence of a significant difference between the two products was found (RD = 2% 90%CI: 5.1%+0.4%; p-value = 0.163). We cannot rule out the possibility of HOCl being inferior by up to 5.1 percentage points and hence we did not strictly meet the non-inferiority margin we set ourselves. However even a maximum difference of 5.1% in favour of sodium hypochlorite would not suggest there is a clinically relevant difference between the two products. We demonstrated that HOCl and NaOCl have a similar efficacy in achieving microbiological cleanliness with HOCl acting at a lower concentration. With a better safety profile and potential applicability across many healthcare uses HOCl provides an attractive and potentially cost-efficient alternative to sodium hypochlorite in low resource settings.
Published: 2022-04-26
Journal: Microorganisms
DOI: 10.3390/microorganisms10050910
DOI_URL: http://doi.org/10.3390/microorganisms10050910
Author Name: Gon Giorgia
Author link: https://covid19-data.nist.gov/pid/rest/local/author/gon_giorgia
Author Name: Dansero Lucia
Author link: https://covid19-data.nist.gov/pid/rest/local/author/dansero_lucia
Author Name: Aiken Alexander M
Author link: https://covid19-data.nist.gov/pid/rest/local/author/aiken_alexander_m
Author Name: Bottomley Christian
Author link: https://covid19-data.nist.gov/pid/rest/local/author/bottomley_christian
Author Name: Dancer Stephanie J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/dancer_stephanie_j
Author Name: Graham Wendy J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/graham_wendy_j
Author Name: Ike Olivia C
Author link: https://covid19-data.nist.gov/pid/rest/local/author/ike_olivia_c
Author Name: Lewis Michelle
Author link: https://covid19-data.nist.gov/pid/rest/local/author/lewis_michelle
Author Name: Meakin Nick
Author link: https://covid19-data.nist.gov/pid/rest/local/author/meakin_nick
Author Name: Okafor Obiora
Author link: https://covid19-data.nist.gov/pid/rest/local/author/okafor_obiora
Author Name: Uwaezuoke Nkolika S
Author link: https://covid19-data.nist.gov/pid/rest/local/author/uwaezuoke_nkolika_s
Author Name: Okwor Tochi Joy
Author link: https://covid19-data.nist.gov/pid/rest/local/author/okwor_tochi_joy
sha: 9e281dbce9e103f94f23f90b6a0673d6586a885f
license: cc-by
license_url: https://creativecommons.org/licenses/by/4.0/
source_x: PMC
source_x_url: https://www.ncbi.nlm.nih.gov/pubmed/
pubmed_id: 35630355
pubmed_id_url: https://www.ncbi.nlm.nih.gov/pubmed/35630355
pmcid: PMC9146012
pmcid_url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9146012
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9146012/
has_full_text: TRUE
Keywords Extracted from Text Content: C. O. L. S. aureus BS/EN 13727 COVID-19 pandemic [1 within-ward human Salvesan Aqueous hypochlorous acid ≥40 surface Sodium hypochlorite dipslide chlorine SARS-CoV-2 coronavirus coagulase locally-generated HOCl low-resourced [7] . sodium hypochlorite Abuja Figure 2 hypochlorite Abuja Federal Capital Territory liquids TEACH purchased S. aureus colonies colourless https://www oxidants −5 AMR CHROMagarTM Staph aureus [7, 8, 13 ] wound care FCT cell Dimanco 90%CI mycobacteria [6 5-35 • C temperature ≥2.5 ≥2.5 cfu/cm 2 BS/EN 1650 patients mucous membranes free radicals [7] HOCI chlorine-like skin Salvesan [7 [13] Confluent saline LMICs latex Nigeria's National Health Research Ethics Committee approval is~7 BS/EN 13704 ACC/cm 2 Human Services Ethics Committee COVID-19 Cleaners patient trihalomethanes S. aureus isolates NaOCl cells participants sodium chlorate BS/EN C. human pathogens [6 Staphylococcus aureus produce~1400 hypochlorous acid water bottled blood RedCAP lshtm.ac.uk/research/centres/march-centre/soapbox-collaborative/teach-clean https://www.cdc.gov/hai/ pdfs/resource-limited/environmental-cleaning-RLS-H.pdf HOCl SalvesanTM sodium hypochlorite purchased UK EWASH Salvesan company-Nick
Extracted Text Content in Record: First 5000 Characters:Citation: Gon, G.; Dansero, L.; Aiken, A.M.; Bottomley, C.; Dancer, S.J.; Graham, W.J.; Ike, O.C.; Lewis, M.; Meakin, N.; Okafor, O.; et al. Low-resourced hospitals in African countries and elsewhere face substantial challenges in ensuring environmental hygiene standards are maintained, as shown in both the West African Ebola virus epidemic and the COVID-19 pandemic [1] . The importance of Microorganisms 2022, 10, 910 2 of 11 environmental hygiene in Africa is heightened by role of antimicrobial resistance (AMR), reported to have the highest rates of death in sub-Saharan Africa [2] . One substantial problem for these hospitals is a continued reliance on commercial sodium hypochlorite (NaOCl)-commonly called "bleach". This product requires accurate daily dilution with water prior to use, but most African hospitals, as with other hospitals in other low resource settings, do not provide any formal training for cleaning staff on use of disinfectants [3] . Additionally, supply chains for hypochlorite products can be problematic with lack of quality control, no regard for expiry dates, and inappropriate storage conditions. Indeed, bleach products available in Africa are often of inconsistent quality, affecting potency [4] . Other limitations of bleach include irritation of skin and mucous membranes if used in poorly ventilated areas, ecological toxicity of key ingredients and by-products, corrosion of surfaces cleaned (including many metals, rubber and some plastics) and bleaching of fabrics. An ideal disinfectant product would achieve a high kill rate of potential pathogens whilst maintaining a good safety profile with low toxicity while permitting simple in-use quality control. These product characteristics are especially important when the environmental cleaning burden is high and there is often overcrowding with insufficient isolation facilities to allow segregation of high-risk infectious patients. This is the scenario faced by many hospitals in low resource countries. The well-known limitations of sodium hypochlorite have encouraged interest in alternative disinfectants for use in hospitals, and in particular the use of locally-sourced disinfectants to avoid issues with product degradation. One alternative disinfectant can be produced locally by saline electrolysis [5, 6] ; hence, these products may be termed electrolysed water. The active ingredients resulting from electrolysis include chlorine, hypochlorous acid and hypochlorite ions or a combination of these. Of these, hypochlorous acid offers the most useful antimicrobial properties-the pure form of this compound can be highly microbiocidal with minimal toxicity. This type of electrolysis can achieve a higher purity of available hypochlorous acid than can be delivered using traditional bleach manufacturing process [7] . Sodium hypochlorite solutions (ie bleach) also largely achieve microbicidal effects through conversion of hypochlorite to hypochlorous acid, but with many inadvertent by-products. Modern electrolysis cells can produce hypochlorous acid in a neutral solution with a pH of approximately 6-8 [8, 9] . Aqueous hypochlorous acid is emerging as a potent and environmentally safe disinfectant available. This compound, in appropriate concentrations, can rapidly inhibit or kill a wide range of human pathogens [6] , including bacteria and spores, viruses such as the SARS-CoV-2 coronavirus [10, 11] , fungi, protozoa and mycobacteria [6, 12] . Correctly managed, electrolysis can provide a relatively pure solution of hypochlorous acid along with other active oxidants and free radicals [7] . Improvements in the manufacturing process for hypochlorous acid (HOCl) offers stable solutions of HOCl in industrial quantities and is widely used in infection control in high-income countries and the food sector in low and middle income countries. Specifically, SalvesanTM is a disinfectant produced by Aqualution (Duns, UK), which is generated through electrolysis. Its chemical composition is 99% HOCl and 1% hypochlorite. This product can achieve rapid surface disinfection at a lower concentration compared with standard commercial sodium hypochlorite and hence has a higher safety profile. The pH of this product is~7 which permits stability over a 12-month shelf life. This contrasts with other commercial hypochlorous acid products, which are only usually viable for hours to days [13] . The ecological residue from HOCI is negligible because it reverts to salt and water, and is therefore less toxic for both environment and users than bleach (sodium hypochlorite) whose degradation products include sodium chlorate and trihalomethanes which are substances of concern, being recognized carcinogens. Previous studies have demonstrated that hypochlorous acid produced by electrolysis and traditional sodium hypochlorite solution can have similar levels of microbiocidal effectiveness [7, 8, 13 ] but we are not aware of any previous randomised trials of effectiveness in a low resou
Keywords Extracted from PMC Text: Colony Counts (ACC)/cm2 mucous membranes [7,8,13] " Abuja S. aureus Human Services Ethics Committee BS/EN oxidants patient free radicals [7] 90%CI SalvesanTM bottled Cleaners HOCI https://www.lshtm.ac.uk/research/centres/march-centre/soapbox-collaborative/teach-clean patients COVID-19 BS/EN 1650 Salvesan [7 purchased [16,21] TEACH sodium chlorate Abuja Federal Capital Territory sodium hypochlorite trihalomethanes [7]. participants SARS-CoV-2 coronavirus human −5.1%–+0.4 sodium hypochlorite purchased AMR BS/EN 13727 NaOCl hypochlorite https://www.cdc.gov/hai/pdfs/resource-limited/environmental-cleaning-RLS-H.pdf colourless dipslide cells wound care FCT HOCl chlorine-like human pathogens [6 liquids BS/EN 13704 Nigeria's National Health Research COVID-19 pandemic [1 RedCAP EU bodies low-resourced ≥2.5 cfu/cm2 5–35 °C temperature range zone saline UK Salvesan LMICs chlorine EWASH 6–8 [8,9] surface cluster-period within-ward cell Aqueous hypochlorous acid skin water S. aureus isolates locally-generated HOCl −5 hypochlorous acid Sodium hypochlorite [13]
Extracted PMC Text Content in Record: First 5000 Characters:Low-resourced hospitals in African countries and elsewhere face substantial challenges in ensuring environmental hygiene standards are maintained, as shown in both the West African Ebola virus epidemic and the COVID-19 pandemic [1]. The importance of environmental hygiene in Africa is heightened by role of antimicrobial resistance (AMR), reported to have the highest rates of death in sub-Saharan Africa [2]. One substantial problem for these hospitals is a continued reliance on commercial sodium hypochlorite (NaOCl)—commonly called "bleach". This product requires accurate daily dilution with water prior to use, but most African hospitals, as with other hospitals in other low resource settings, do not provide any formal training for cleaning staff on use of disinfectants [3]. Additionally, supply chains for hypochlorite products can be problematic with lack of quality control, no regard for expiry dates, and inappropriate storage conditions. Indeed, bleach products available in Africa are often of inconsistent quality, affecting potency [4]. Other limitations of bleach include irritation of skin and mucous membranes if used in poorly ventilated areas, ecological toxicity of key ingredients and by-products, corrosion of surfaces cleaned (including many metals, rubber and some plastics) and bleaching of fabrics. An ideal disinfectant product would achieve a high kill rate of potential pathogens whilst maintaining a good safety profile with low toxicity while permitting simple in-use quality control. These product characteristics are especially important when the environmental cleaning burden is high and there is often overcrowding with insufficient isolation facilities to allow segregation of high-risk infectious patients. This is the scenario faced by many hospitals in low resource countries. The well-known limitations of sodium hypochlorite have encouraged interest in alternative disinfectants for use in hospitals, and in particular the use of locally-sourced disinfectants to avoid issues with product degradation. One alternative disinfectant can be produced locally by saline electrolysis [5,6]; hence, these products may be termed electrolysed water. The active ingredients resulting from electrolysis include chlorine, hypochlorous acid and hypochlorite ions or a combination of these. Of these, hypochlorous acid offers the most useful antimicrobial properties—the pure form of this compound can be highly microbiocidal with minimal toxicity. This type of electrolysis can achieve a higher purity of available hypochlorous acid than can be delivered using traditional bleach manufacturing process [7]. Sodium hypochlorite solutions (ie bleach) also largely achieve microbicidal effects through conversion of hypochlorite to hypochlorous acid, but with many inadvertent by-products. Modern electrolysis cells can produce hypochlorous acid in a neutral solution with a pH of approximately 6–8 [8,9]. Aqueous hypochlorous acid is emerging as a potent and environmentally safe disinfectant available. This compound, in appropriate concentrations, can rapidly inhibit or kill a wide range of human pathogens [6], including bacteria and spores, viruses such as the SARS-CoV-2 coronavirus [10,11], fungi, protozoa and mycobacteria [6,12]. Correctly managed, electrolysis can provide a relatively pure solution of hypochlorous acid along with other active oxidants and free radicals [7]. Improvements in the manufacturing process for hypochlorous acid (HOCl) offers stable solutions of HOCl in industrial quantities and is widely used in infection control in high-income countries and the food sector in low and middle income countries. Specifically, SalvesanTM is a disinfectant produced by Aqualution (Duns, UK), which is generated through electrolysis. Its chemical composition is 99% HOCl and 1% hypochlorite. This product can achieve rapid surface disinfection at a lower concentration compared with standard commercial sodium hypochlorite and hence has a higher safety profile. The pH of this product is ~7 which permits stability over a 12-month shelf life. This contrasts with other commercial hypochlorous acid products, which are only usually viable for hours to days [13]. The ecological residue from HOCI is negligible because it reverts to salt and water, and is therefore less toxic for both environment and users than bleach (sodium hypochlorite) whose degradation products include sodium chlorate and trihalomethanes which are substances of concern, being recognized carcinogens. Previous studies have demonstrated that hypochlorous acid produced by electrolysis and traditional sodium hypochlorite solution can have similar levels of microbiocidal effectiveness [7,8,13] but we are not aware of any previous randomised trials of effectiveness in a low resourced settings. We aimed to assess the efficacy of HOCl against standard sodium hypochlorite (both used at recommended concentrations) for hospital cleaning across six wards of two hospitals in Abu
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