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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
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Scientific title
Economic, social and cross cultural issues in non-pharmaceutical protection of front line responders to pandemic influenza and emerging infections
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Secondary ID [1]
252852
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NA
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Seasonal influenza, viral or bacterial respiratory infections
258373
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Condition category
Condition code
Infection
258546
258546
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
257370
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Prevention
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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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.
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Primary outcome [2]
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Influenza-like illness (ILI): defined as fever (>38C) plus one respiratory symptom.
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Assessment method [2]
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Timepoint [2]
259384
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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.
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Primary outcome [3]
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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
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Assessment method [3]
259385
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Timepoint [3]
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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.
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Secondary outcome [1]
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Laboratory confirmed virus (any respiratory virus)
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Assessment method [1]
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Timepoint [1]
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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.
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Secondary outcome [2]
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Laboratory-confirmed influenza A or B
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Assessment method [2]
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Timepoint [2]
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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.
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Secondary outcome [3]
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Laboratory confirmed bacterial respiratory infection (any)
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Assessment method [3]
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Timepoint [3]
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Laboratory confirmed bacterial respiratory infection (any). The testing will be done only if the budget allows
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Secondary outcome [4]
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Compliance with mask use
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Assessment method [4]
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Timepoint [4]
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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.
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Secondary outcome [5]
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Adherence, relationship of compliance to risk perception and barriers to compliance in HCWs.
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Assessment method [5]
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Timepoint [5]
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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.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/03/2011
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Actual
3/03/2011
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Date of last participant enrolment
Anticipated
11/03/2011
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Actual
11/03/2011
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
1600
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Accrual to date
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Final
1607
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Recruitment outside Australia
Country [1]
2964
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Viet Nam
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State/province [1]
2964
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Hanoi
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Research Council
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Address [1]
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GPO Box 2702
CANBERRA
ACT 2601
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of New South Wales
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Address
School of Public Health and Community Medicine
Samuels Building
The University of New South Wales
Sydney NSW 2052
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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National Institute of Hygiene and Epidemiology
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Address [1]
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No 1 Yersin St
Hai Ba Trung, Hanoi,
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Country [1]
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Viet Nam
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Other collaborator category [1]
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Hospital
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Name [1]
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Institute of Clinical Pathology and Medical Research, Westmead Hospital
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Address [1]
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Westmead Hospital
Po Box 533, Wentworthville, NSW, 2145
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Country [1]
251553
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Australia
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Other collaborator category [2]
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University
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Name [2]
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School of Public Health, Imperial College
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Address [2]
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School of Public Health
Medical School
Exhibition Road
St Mary's Campus, Imperial College
London SW7 2AZ
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Country [2]
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United Kingdom
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of New South Wales
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Ethics committee address [1]
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UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
Sydney
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/09/2010
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Approval date [1]
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02/11/2010
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Ethics approval number [1]
259852
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10306
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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)
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Trial website
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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
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Public notes
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Contacts
Principal investigator
Name
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Prof Raina MacIntyre
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Address
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School of Public Health and Community Medicine
Level 3, Samuels Building
University of New South Wales
Sydney, NSW, 2031
Australia
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Country
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Australia
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Phone
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+61 2 9385 2517
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Fax
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+61 2 9313 6185
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Holly Seale
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Address
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School of Public Health and Community Medicine
Level 3, Samuels Building
The University of New South Wales
Sydney NSW 2052
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Country
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Australia
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Phone
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+61 2 9385 3129
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Fax
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+61 2 9313 6185
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Raina MacIntyre
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Address
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School of Public Health and Community Medicine
Level 3, Samuels Building
The University of New South Wales
Sydney NSW 2052
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Country
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Australia
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Phone
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+61 2 9385 2517
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Fax
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+61 2 9313 6185
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
A cluster randomised trial of cloth masks compared with medical masks in healthcare workers.
2015
https://dx.doi.org/10.1136/bmjopen-2014-006577
N.B. These documents automatically identified may not have been verified by the study sponsor.
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