Evidence map›Paper›PMID 25903751›Full record

Trial reportBMJ open2015

A cluster randomised trial of cloth masks compared with medical masks in healthcare workers.

C Raina MacIntyre, Holly Seale, Tham Chi Dung, Nguyen Tran Hien, Phan Thi Nga, Abrar Ahmad Chughtai, Bayzidur Rahman, Dominic E Dwyer, Quanyi Wang

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05036941 (A Cluster Randomized Trial of Two Mask Systems), which is not on this map. Cited by 193 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
193citing papers in PubMed, 19 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05036941 naunknown statusnot on this mapstarted 2021, after this paper: background citation

A Cluster Randomized Trial of Two Mask Systems (Acteev™ N95 + Acteev™ Fabric Masks vs. Standard N95 + Fabric Masks During Shifts & in Community) in Preventing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) in HCWs

TypeinterventionalSponsorAscend Performance MaterialsRan2021 to 2022Enrolled1,600ConditionsSARS CoV-2 Infection, Influenza -Like IllnessArmsActeev™ Masks, Comparison Masks
3 · Its place in the literature

Who cites it

193 citing papers in PubMed, 19 syntheses or guidelines pooled it.

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  11. Facemask use in community settings to prevent respiratory infection transmission: A rapid review and meta-analysis.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2021
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  18. Effectiveness of Masks and Respirators Against Respiratory Infections in Healthcare Workers: A Systematic Review and Meta-Analysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017
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  19. Uptake and effectiveness of facemask against respiratory infections at mass gatherings: a systematic review.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2016
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  20. Trial

133 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

C Raina MacIntyreFaculty of Medicine, School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.
Holly SealeFaculty of Medicine, School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.
Tham Chi DungNational Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
Nguyen Tran HienNational Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
Phan Thi NgaNational Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
Abrar Ahmad ChughtaiFaculty of Medicine, School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.
Bayzidur RahmanFaculty of Medicine, School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.
Dominic E DwyerInstitute for Clinical Pathology and Medical Research, Westmead Hospital and University of Sydney, Sydney, New South Wales, Australia.
Quanyi WangBeijing Centers for Disease Control and Prevention, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to compare the efficacy of cloth masks to medical masks in hospital healthcare workers (HCWs). The null hypothesis is that there is no difference between medical masks and cloth masks.

setting14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam.

participants1607 hospital HCWs aged ≥18 years working full-time in selected high-risk wards.

interventionHospital wards were randomised to: medical masks, cloth masks or a control group (usual practice, which included mask wearing). Participants used the mask on every shift for 4 consecutive weeks.

main outcome measureClinical respiratory illness (CRI), influenza-like illness (ILI) and laboratory-confirmed respiratory virus infection.

resultsThe rates of all infection outcomes were highest in the cloth mask arm, with the rate of ILI statistically significantly higher in the cloth mask arm (relative risk (RR)=13.00, 95% CI 1.69 to 100.07) compared with the medical mask arm. Cloth masks also had significantly higher rates of ILI compared with the control arm. An analysis by mask use showed ILI (RR=6.64, 95% CI 1.45 to 28.65) and laboratory-confirmed virus (RR=1.72, 95% CI 1.01 to 2.94) were significantly higher in the cloth masks group compared with the medical masks group. Penetration of cloth masks by particles was almost 97% and medical masks 44%.

conclusionsThis study is the first RCT of cloth masks, and the results caution against the use of cloth masks. This is an important finding to inform occupational health and safety. Moisture retention, reuse of cloth masks and poor filtration may result in increased risk of infection. Further research is needed to inform the widespread use of cloth masks globally. However, as a precautionary measure, cloth masks should not be recommended for HCWs, particularly in high-risk situations, and guidelines need to be updated. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry: ACTRN12610000887077.

Indexed as

AdultAgedAustraliaCluster AnalysisFemaleHumansInfection ControlInfluenza, HumanMaleMasksMiddle AgedNew ZealandOccupational ExposureOccupational Health ServicesPersonnel, HospitalRespiratory Protective DevicesRNA, ViralCloth maskInfluenza

Identifiers

PMID25903751
PMCPMC4420971

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.