Randomised Trial of Cloth Masks Compared with Medical Masks in Healthcare Workers

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 laboratory-confirmed 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 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%.
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.

Strengths and limitations of this study:

1. The use of cloth masks is widespread around the world, particularly in countries at high-risk for emerging infections, but there have been no efficacy studies to underpin their use.
2. This study is large, a prospective randomised clinical trial (RCT) and the first RCT ever conducted of cloth masks.
3. The use of cloth masks are not addressed in most guidelines for health care workers—this study provides data to update guidelines.
4. The control arm was ‘standard practice’, which comprised mask use in a high proportion of participants. As such (without a no-mask control), the finding of a much higher rate of infection in the cloth mask arm could be interpreted as harm caused by cloth masks, efficacy of medical masks, or most likely a combination of both.

REFERENCE:
MacIntyre, CR et al. “A Cluster Randomised Trial of Cloth Masks Compared with Medical Masks in Healthcare Workers.” BMJ Open 5.4 (2015): e006577. PMC. Web. 16 Apr. 2016.

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