A cluster randomised trial of cloth
masks compared with medical masks
in healthcare workers
C Raina MacIntyre,1 Holly Seale,1 Tham Chi Dung,2 Nguyen Tran Hien,2
Phan Thi Nga,2 Abrar Ahmad Chughtai,1 Bayzidur Rahman,1 Dominic E Dwyer,3
Quanyi Wang4
To cite: MacIntyre CR,
Seale H, Dung TC, et al.
A cluster randomised trial of
cloth masks compared with
medical masks in healthcare
workers. BMJ Open 2015;5:
e006577. doi:10.1136/
bmjopen-2014-006577
▸
Received 9 September 2014
Revised 25 March 2015
Accepted 26 March 2015
For numbered affiliations see
end of article.
Correspondence to
Professor C Raina
ABSTRACT
Objective: The 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.
Setting: 14 secondary-level/tertiary-level hospitals in
Hanoi, Vietnam.
Participants: 1607 hospital HCWs aged ≥18 years
working full-time in selected high-risk wards.
Intervention: Hospital 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 measure: Clinical respiratory illness
(CRI), influenza-like illness (ILI) and laboratoryconfirmed respiratory virus infection.
Results: The 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 laboratoryconfirmed 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%.
Conclusions: This 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 Z