ANZCTR - Registration

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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]

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

Condition category

Condition code

Infection

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]

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]

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]

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]

Influenza-like illness (ILI): defined as fever (>38C) plus one respiratory symptom.

Timepoint [2]

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]

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]

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]

Laboratory confirmed virus (any respiratory virus)

Timepoint [1]

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]

Laboratory-confirmed influenza A or B

Timepoint [2]

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]

Laboratory confirmed bacterial respiratory infection (any)

Timepoint [3]

Laboratory confirmed bacterial respiratory infection (any). The testing will be done only if the budget allows

Secondary outcome [4]

Compliance with mask use

Timepoint [4]

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]

Adherence, relationship of compliance to risk perception and barriers to compliance in HCWs.

Timepoint [5]

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

Sex

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

1/03/2011

Actual

3/03/2011

Date of last participant enrolment

Anticipated

11/03/2011

Actual

11/03/2011

Date of last data collection

Anticipated

Actual

Sample size

Target

1600

Accrual to date

Final

1607

Recruitment outside Australia

Country [1]

Viet Nam

State/province [1]

Hanoi

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Research Council

Address [1]

GPO Box 2702
CANBERRA
ACT 2601

Country [1]

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]

University

Name [1]

National Institute of Hygiene and Epidemiology

Address [1]

No 1 Yersin St
Hai Ba Trung, Hanoi,

Country [1]

Viet Nam

Other collaborator category [1]

Hospital

Name [1]

Institute of Clinical Pathology and Medical Research, Westmead Hospital

Address [1]

Westmead Hospital
Po Box 533, Wentworthville, NSW, 2145

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

School of Public Health, Imperial College

Address [2]

School of Public Health
Medical School
Exhibition Road
St Mary's Campus, Imperial College
London SW7 2AZ

Country [2]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales

Ethics committee address [1]

UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
Sydney

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/09/2010

Approval date [1]

02/11/2010

Ethics approval number [1]

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

Prof Raina MacIntyre

Address

School of Public Health and Community Medicine
Level 3, Samuels Building
University of New South Wales
Sydney, NSW, 2031
Australia

Country

Australia

Phone

+61 2 9385 2517

Fax

+61 2 9313 6185

Email

[email protected]

Contact person for public queries

Name

Holly Seale

Address

School of Public Health and Community Medicine
Level 3, Samuels Building
The University of New South Wales
Sydney NSW 2052

Country

Australia

Phone

+61 2 9385 3129

Fax

+61 2 9313 6185

Email

[email protected]

Contact person for scientific queries

Name

Raina MacIntyre

Address

School of Public Health and Community Medicine
Level 3, Samuels Building
The University of New South Wales
Sydney NSW 2052

Country

Australia

Phone

+61 2 9385 2517

Fax

+61 2 9313 6185

Email

[email protected]

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.