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The first randomised, controlled clinical trial of surgical masks compared to fit-tested and non-fit tested N95 masks in the prevention of respiratory virus infection in hospital health care workers in Beijing, China.

Randomised control trial of health care workers using N95 and surgical masks in prevention of clinical and viral respiratory infection

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000257268
Enrollment
1441
Registered
2009-05-13
Start date
2008-12-01
Completion date
2008-12-19
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the study is to determine the efficacy of surgical masks compared to fit tested and non-fit tested N95 masks in health care workers in the prevention of influenza and other respiratory viruses.

Interventions

Intervention: Surgical masks (Arm 1), N95 masks (fit tested, Arm 2), N95 masks (not fit tested, Arm 3), Control (No masks, Arm 4) Participants will be provided with surgical masks or N95 masks, (depending on which hospital they work in) to be worn for four weeks when working on the ward. Masks will be worn when participants are working in the emergency department or respiratory ward; they will be allowed to remove the mask when: (1) they exit the department/ward; and (2) enter the tea room for m

Intervention: Surgical masks (Arm 1), N95 masks (fit tested, Arm 2), N95 masks (not fit tested, Arm 3), Control (No masks, Arm 4) Participants will be provided with surgical masks or N95 masks, (depending on which hospital they work in) to be worn for four weeks when working on the ward. Masks will be worn when participants are working in the emergency department or respiratory ward; they will be allowed to remove the mask when: (1) they exit the department/ward; and (2) enter the tea room for meal breaks. Subjects recruited to Arm 2 will have the masks correctly fit-tested using a 3M (trademark) FT-30 Bitrex Fit Test Kit according to the manufacturers’ instructions (3M, St Paul, Minnesota (MN), USA). This kit uses a nebulized solution sprayed into an enclosed chamber and relies on the subject tasting the solution through the mask. If the subject is able to taste the solution, the mask is incorrectly fitted and needs to be re-fitted until the subject cannot taste the solution. All participants will be followed up for five weeks (which includes four weeks of wearing the masks and an extra week of non-mask wearing)

Sponsors

University of New South Wales
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Any nurse or doctor who works full time in the selected ward at the study hospitals in Beijing, China.

Exclusion criteria

Inability or refusal to consent Males with beards, long moustaches or long facial hair stubble Clinical staff with a current respiratory illness, rhinitis and/or allergy Part-time worker Does not work on the abovementioned wards

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 29, 2026