ArticlePloS one2021
Study of the use of a personalized peripheral sealing device on surgical face masks in high-risk situations against COVID-19.
Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.
- A systematic review of fit improvement strategies for respirators: lessons learned from the COVID-19 pandemic.BMC public health · 2025Pooled it
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A significant number of health care professionals subjected to high-risk situations have been infected by Covid-19 due to the lack of adequate protection equipment or the deficient safety margins that these present. The aim of this study was to investigate whether the use of a personal peripheral sealing device (PSD) on surgical face masks (SM) allows them to achieve double mask properties, by providing two-way protection to professionals or users. The proposed device is a thermoplastic resin ring composed of a reusable and biodegradable polylactic acid (PLA) designed to be used in a healthcare setting. Since it is a thermoplastic device, it can be molded and adapted to each individual, becoming personalized and ensuring a correct adjustment to the user's face. First, a qualitative fit test was performed using a saccharin solution (SS) to evaluate respiratory protective equipment in recruited professionals exposed to high-risk situations of infection by Covid-19. Individuals were divided into an intervention group, who used SM with the PSD, and a control group, who used SM without the PSD. In addition, a quantitative inward air leakage fit test was performed using a 2% sodium chloride (NaCl) aerosol in a sealed cabinet with probes sensitive to this substance, in order to validate the SM with the PSD as a Face Filtering Mask (FFP). Only 5% of the individuals who performed the qualitative fit test with the PSD perceived the sweet taste of the SS, while 100% of the individuals who performed the test without the PSD sensed it (p = 0.0001). In the quantitative fit test, the percentage of air leakage of 2% NaCl aerosol into the SM with the PSD was 6.5%, achieving the same range of air leakage as a FFP mask. Thus, the use of a personalized PLA thermoplastic PSD, together with an inexpensive and widely available SM, could have a significant impact in terms of preventive safety by providing bi-directional protection to its user.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.