Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000388718
Ethics application status
Approved
Date submitted
1/02/2022
Date registered
7/03/2022
Date last updated
7/03/2022
Date data sharing statement initially provided
7/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the effect of 3D printed facial guards on leak from P2/N95 respirators
Scientific title
Investigating the effect of 3D printed facial guards on quantitative fit of P2/N95 respirators for health care workers
Secondary ID [1] 306311 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Face mask fit in health care workers 325066 0
Condition category
Condition code
Respiratory 322501 322501 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project will involve the evaluation of 3D-printed facial guards on N95 face mask leak. Participants in the study will have a face scan with a mobile phone app, that acquires a 3D topographic geometry of the face. Using this scan, a customised face guard is 3D-printed by our engineering team. Following fitting, each participant will have Portacount quantitative fit testing performed by a resarch fellow or nurse, with an N95 worn in the standard fashion, and with the 3D-printed face guard in combination with an N95. Purposeful randomised sampling of the SALHN WHS database will be performed to select n=85 participants who have previously failed quantitative N95 fit testing (who will become the interventional group receiving a 3D-printed facial guard plus P2/N95). Each participant will have approximately 15 minute taken with a scanning visit, and then a 30-45 minute second visit for testing.
Intervention code [1] 322736 0
Treatment: Devices
Comparator / control treatment
Standard N95 masks alone. Each participant is their own control for the primary endpoint of the study.
Control group
Active

Outcomes
Primary outcome [1] 330291 0
Quantitative fit factor on Portacount testing on 3D Face guard +N95 vs standard N95 alone
Timepoint [1] 330291 0
At time of fit test
Secondary outcome [1] 405597 0
Proportion of health care workers passing quantitative fit test with 3D face guard vs control group
Timepoint [1] 405597 0
At time of fit test

Eligibility
Key inclusion criteria
Any health care worker or SA Health employee who has undergone quantitative fit testing. Purposeful randomised sampling of the SALHN WHS database will be performed to select n=85 participants who have previously failed quantitative N95 fit testing (who will become the interventional group receiving a 3D-printed facial guard plus P2/N95). A second group of n=85 participants who have previously passed quantitative fit tests will be selected for re-testing with P2/N95 masks as a control group, to ensure that a contemporaneous control group is analysed under the same conditions as the interventional group.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Are based on current exclusions from SA Health fit testing guidelines: (i) Active asthma or respiratory condition requiring treatment may be a relative contraindication to fit testing; (ii) Pregnancy; (iii) Active upper respiratory tract infection, fever, or other suspected infection.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Analysis and Health Economic Evaluation
Mixed effect linear regression model will be applied to fit linear mixed models to examine the primary and secondary outcomes. To allow for the non-independence of study participants with repeated time points, a two-level random intercept regression model will be used to explore outcome variation. Mixed effect models will capture both fixed and random effects within the hierarchical data structure (follow-up time nested with participants). Fixed effects including group effect, time effect and group x time interaction will be determined. Univariate models will be first used, then a multivariate modelling undertaken by adding variables considered clinically important or statistically significant to adjust for confounding effects. Interaction of variables will be further examined to see any significant differences of outcome measures between variables. Two-sided tests will be performed for all analyses and the level of significance set at p <0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
170
Accrual to date
65
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 36528 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 310655 0
Government body
Name [1] 310655 0
Medical Research Future Fund
Country [1] 310655 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
1 Flinders Drive Bedford Park
South Australia 5042
Country
Australia
Secondary sponsor category [1] 312145 0
None
Name [1] 312145 0
None
Address [1] 312145 0
None
Country [1] 312145 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310249 0
Southern Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 310249 0
1 Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 310249 0
Australia
Date submitted for ethics approval [1] 310249 0
01/05/2021
Approval date [1] 310249 0
12/05/2021
Ethics approval number [1] 310249 0
21.21

Summary
Brief summary
COVID-19 is a major global pandemic. A current major issue in countries dealing with COVID-19 is the availability of safe and effective masks for health care workers. The current recommended gold standard mask is the P2/N95 mask for health care workers in high exposure environments. Unfortunately, for many health care workers, there continues to be residual peri-mask leak with existing off-the-shelf standard mask designs. In this project, we develop customized 3D-printed facial shields that could be worn by health care workers as a supplementary barrier to prevent peri-mask leak.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117002 0
A/Prof Anand Ganesan
Address 117002 0
Flinders Medical Centre
1 Flinders Drive
Bedford Park SA 5042
Country 117002 0
Australia
Phone 117002 0
+61 8 82045619
Fax 117002 0
Email 117002 0
[email protected]
Contact person for public queries
Name 117003 0
A/Prof Anand Ganesan
Address 117003 0
Flinders Medical Centre
1 Flinders Drive
Bedford Park SA 5042
Country 117003 0
Australia
Phone 117003 0
+61 8 82045619
Fax 117003 0
Email 117003 0
[email protected]
Contact person for scientific queries
Name 117004 0
A/Prof Anand Ganesan
Address 117004 0
Flinders Medical Centre
1 Flinders Drive
Bedford Park SA 5042
Country 117004 0
Australia
Phone 117004 0
+61 8 82045619
Fax 117004 0
Email 117004 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study is a pilot study, involving participant data. No permission has been obtained from participants to allow data sharing.


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
SourceTitleYear of PublicationDOI
EmbasePersonalized 3D-printed frames to reduce leak from N95 filtering facepiece respirators: A prospective crossover trial in health care workers.2023https://dx.doi.org/10.1080/15459624.2023.2205471
N.B. These documents automatically identified may not have been verified by the study sponsor.