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Trial registered on ANZCTR


Registration number
ACTRN12610000887077
Ethics application status
Approved
Date submitted
18/10/2010
Date registered
19/10/2010
Date last updated
29/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Face masks in the protection of healthcare workers to pandemic influenza and emerging infections
Scientific title
Economic, social and cross cultural issues in non-pharmaceutical protection of front line responders to pandemic influenza and emerging infections
Secondary ID [1] 252852 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seasonal influenza, viral or bacterial respiratory infections 258373 0
Condition category
Condition code
Infection 258546 258546 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm One: Cloth or material mask
In this trial, participants will be asked to wear the mask continuously on every shift (around 8 hours) for a four week period. They are to remove the mask when: they exit the department/ward or when they enter the tea room for a break

Arm two: Surgical mask
Surgical masks-are loose-fitting facial coverings that are designed to prevent wound contamination in the patient from the cough or exhaled secretions of the physician, nurse or other healthcare worker.
In this trial, participants will be asked to wear the mask continuously on every shift (around 8 hours) for a four week period. They are to remove the mask when: they exit the department/ward or when they enter the tea room for a break
Intervention code [1] 257370 0
Prevention
Comparator / control treatment
Arm three: Control
Participants will continue to use the infection control methods including the use of masks, that are standard in the ward/department. Detailed information will be collected regarding the use of personal protective equipment.
Control group
Active

Outcomes
Primary outcome [1] 259382 0
Two symptoms, systemic (fever, myalgia, arthralgia, headache) or respiratory (cough, sore throat, sneezing, rinorrhoea, shortness of breath), at least one of which must be a respiratory symptom. A standard list of symptoms will be used to assess the outcome.
Timepoint [1] 259382 0
This outcome will be assessed (by interviewing the participant) on a daily basis over a five week period. Time to development of outcome will be measured.
Primary outcome [2] 259384 0
Influenza-like illness (ILI): defined as fever (>38C) plus one respiratory symptom.
Timepoint [2] 259384 0
This outcome will be assessed (by interviewing the participant) on a daily basis over a five week period. Time to development of outcome will be measured.
Primary outcome [3] 259385 0
Laboratory-confirmed viral or bacterial respiratory infection: adenoviruses, human metapneumovirus, influenza A or B, coronaviruses 229E/NL63, parainfluenzaviruses 1, 2 and 3, respiratory syncytial virus A and B, rhinovirus A/B and coronavirus OC43/HKU1, streptococcus pneumoniae, legionella sp., bordetella pertussis, chlamydia, mycoplasma or haemophilus influenzae type B
Timepoint [3] 259385 0
This outcome will be assessed (by interviewing the participant) on a daily basis over a five week period. Time to development of outcome will be measured.
Secondary outcome [1] 265914 0
Laboratory confirmed virus (any respiratory virus)
Timepoint [1] 265914 0
This outcome will be assessed (by interviewing the participant) on a daily basis over a five week period. Time to development of outcome will be measured.
Secondary outcome [2] 265915 0
Laboratory-confirmed influenza A or B
Timepoint [2] 265915 0
This outcome will be assessed (by interviewing the participant) on a daily basis over a five week period. Time to development of outcome will be measured.
Secondary outcome [3] 265916 0
Laboratory confirmed bacterial respiratory infection (any)
Timepoint [3] 265916 0
Laboratory confirmed bacterial respiratory infection (any). The testing will be done only if the budget allows
Secondary outcome [4] 265917 0
Compliance with mask use
Timepoint [4] 265917 0
A diary card with tick boxes for the mask use will be given to each subject, which they will carry with them during the day. They will tick the responses after each shift. Adherence to wearing the mask will be monitored by use of diary cards which will be returned to researchers on a weekly basis.
Secondary outcome [5] 265918 0
Adherence, relationship of compliance to risk perception and barriers to compliance in HCWs.
Timepoint [5] 265918 0
Participants will be surveyed at the end of the four week period to gain further insights into adherence and other issues around the use of masks including adverse effects. We will specifically ask about pain, discomfort, skin necrosis, difficulty breathing, headaches, adherence to infection control protocol associated with face mask use (hand hygiene, face touching etc) and perceptions about patient communication issues associated with mask wearing. A random sample of subjects will be selected for in-depth qualitative interviews.

Eligibility
Key inclusion criteria
Any nurse or doctor who works full time at the hospital. Other staff members may be included if they are assessed to have regular contact with patients i.e. triage staff, ancillary staff
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Males with beards, long moustaches or long facial hair stubble
2) Clinical staff with a current respiratory illness, rhinitis and/or allergies (Staff who report having a respiratory illness at the time of recruitment will have their participation delayed by two weeks once they have become asymptomatic)
3) Part-time worker

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The unit of randomisation will be the ward/department, which will be randomised to one of the three trial arms. Allocation concealment cannot be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A secure computerised randomisation program will be used to cluster randomise the departments/wards
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2964 0
Viet Nam
State/province [1] 2964 0
Hanoi

Funding & Sponsors
Funding source category [1] 257822 0
Government body
Name [1] 257822 0
Australian Research Council
Address [1] 257822 0
GPO Box 2702
CANBERRA
ACT 2601
Country [1] 257822 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Public Health and Community Medicine
Samuels Building
The University of New South Wales
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 257024 0
University
Name [1] 257024 0
National Institute of Hygiene and Epidemiology
Address [1] 257024 0
No 1 Yersin St
Hai Ba Trung, Hanoi,
Country [1] 257024 0
Viet Nam
Other collaborator category [1] 251553 0
Hospital
Name [1] 251553 0
Institute of Clinical Pathology and Medical Research, Westmead Hospital
Address [1] 251553 0
Westmead Hospital
Po Box 533, Wentworthville, NSW, 2145
Country [1] 251553 0
Australia
Other collaborator category [2] 251554 0
University
Name [2] 251554 0
School of Public Health, Imperial College
Address [2] 251554 0
School of Public Health
Medical School
Exhibition Road
St Mary's Campus, Imperial College
London SW7 2AZ
Country [2] 251554 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259852 0
University of New South Wales
Ethics committee address [1] 259852 0
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
Sydney
Ethics committee country [1] 259852 0
Australia
Date submitted for ethics approval [1] 259852 0
01/09/2010
Approval date [1] 259852 0
02/11/2010
Ethics approval number [1] 259852 0
10306

Summary
Brief summary
A prospective, three-armed cluster randomized trial of mask use in health care workers (HCWs) to determine the effectiveness/efficacy of two different kinds of face masks (cloth masks and surgical masks) during the influenza season on the transmission of seasonal influenza and other respiratory infectious agents. Other respiratory viruses such as respiratory syncytial virus (RSV), adenovirus, parainfluenza viruses, coronaviruses, human metapneumovirus (hMPV), rhinoviruses etc are also associated with outbreaks of acute respiratory disease. Health care workers (HCWs) from the emergency departments, respiratory wards, pediatric wards and infectious disease wards of 15 major hospitals in Hanoi, Vietnam will be recruited. These wards are selected because they are a setting in which repeated and multiple exposures to viral respiratory infections are present for staff. Wards/departments will be allocated to one of the three study arms. Participants from the two mask arms will be provided with one of two types of masks(depending on the arm to which the ward/department they work in has been randomised) to be worn for four weeks when working on the ward. Participants in the third arm will continue to carry out there standard practice. All participants will be followed up for five weeks (the four weeks of wearing the masks and an extra week of non-mask wearing)
Trial website
Trial related presentations / publications
C Raina MacIntyre, Holly Seale, Tham Chi Dung, Nguyen Tran Hien, Phan Thi Nga, Abrar Ahmad Chughtai, Bayzidur Rahman, Dominic E Dwyer, Quanyi Wang. A cluster randomised trial of cloth masks compared with medical masks in healthcare workers. BMJ Open 2015;5:4 e006577 doi:10.1136/bmjopen-2014-006577
Public notes

Contacts
Principal investigator
Name 31756 0
Prof Raina MacIntyre
Address 31756 0
School of Public Health and Community Medicine
Level 3, Samuels Building
University of New South Wales
Sydney, NSW, 2031
Australia
Country 31756 0
Australia
Phone 31756 0
+61 2 9385 2517
Fax 31756 0
+61 2 9313 6185
Email 31756 0
r.macintyre@unsw.edu.au
Contact person for public queries
Name 15003 0
Dr Holly Seale
Address 15003 0
School of Public Health and Community Medicine
Level 3, Samuels Building
The University of New South Wales
Sydney NSW 2052
Country 15003 0
Australia
Phone 15003 0
+61 2 9385 3129
Fax 15003 0
+61 2 9313 6185
Email 15003 0
h.seale@unsw.edu.au
Contact person for scientific queries
Name 5931 0
Prof Raina MacIntyre
Address 5931 0
School of Public Health and Community Medicine
Level 3, Samuels Building
The University of New South Wales
Sydney NSW 2052
Country 5931 0
Australia
Phone 5931 0
+61 2 9385 2517
Fax 5931 0
+61 2 9313 6185
Email 5931 0
r.macintyre@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary