Evidence map›Paper›PMID 39333902›Full record

Trial reportBMC infectious diseases2024

Efficacy and feasibility of a novel semi-facial respirator with chitosan nanoparticles on the incidence of SARS-CoV-2 infection in healthcare professionals: randomized controlled trial.

Aline Midori Adati Kubota, Mário Fabrício Fleury Rosa, Solange Baraldi, Janine Araújo Montefusco Vale, Joana D Arc Gonçalves da Silva, Marcella Lemos Brettas Carneiro, Rosimeire Simprini Padula, Rodrigo Haddad, Graziella Anselmo Joanitti, Glécia Virgolino da Silva Luz and 5 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04490200 (Effectiveness of a Novel Respirator With Chitosan Nanoparticles to Reduce the Incidence of SARS-CoV-2 Infection in Healthcare Professionals), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT04490200 nacompletednot on this map

Effectiveness of a Novel Respirator With Chitosan Nanoparticles to Reduce the Incidence of SARS-CoV-2 Infection in Healthcare Professionals: Randomized Controlled Trial (VESTA Trial)

TypeinterventionalSponsorUniversity of BrasiliaRan2021 to 2023Enrolled300ConditionsCovid19, SARS-CoV Infection, Worker-Patient Transmission, HealthcareArmsVESTA respirator, Conventional N95 respirator
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Aline Midori Adati KubotaUniversidade de Brasília (UnB), Brasília, Brazil.
Mário Fabrício Fleury RosaUniversidade de Brasília (UnB), Brasília, Brazil.
Solange BaraldiUniversidade de Brasília (UnB), Brasília, Brazil.
Janine Araújo Montefusco ValeHospital Regional da Asa Norte (HRAN), Brasília, DF, Brazil.
Joana D Arc Gonçalves da SilvaHospital Regional da Asa Norte (HRAN), Brasília, DF, Brazil.
Marcella Lemos Brettas CarneiroUniversidade de Brasília (UnB), Brasília, Brazil.
Rosimeire Simprini PadulaUniversidade Cidade de São Paulo (UNICID), São Paulo, DF, Brazil.
Rodrigo HaddadUniversidade de Brasília (UnB), Brasília, Brazil.
Graziella Anselmo JoanittiUniversidade de Brasília (UnB), Brasília, Brazil.
Glécia Virgolino da Silva LuzUniversidade de Brasília (UnB), Brasília, Brazil.
Marcus Vinícius Lia FookUniversidade Federal de Campina Grande (UFCG), Northeastern Biomaterials Evaluation and Development Laboratory (CERTBIO), Campina Grande, PB, Brazil.
Ivan Ricardo ZimmermannUniversidade de Brasília (UnB), Brasília, Brazil.
Suélia de Siqueira Rodrigues Fleury RosaUniversidade de Brasília (UnB), Brasília, Brazil.
Henry Maia PeixotoUniversidade de Brasília (UnB), Brasília, Brazil.
Rodrigo Luiz CarregaroUniversidade de Brasília (UnB), Brasília, Brazil. rodrigocarregaro@unb.br.

Funding

Conselho Nacional de Desenvolvimento Científico e Tecnológico 307885/2020-8Conselho Nacional de Desenvolvimento Científico e Tecnológico 403472/2020-2Fundação de Apoio à Pesquisa do Distrito Federal 00193-00000736/2021-64Online crowdfunding (VAKINHA) 964530UnB/DPI/FAPDF (COVID-19) 6913
6 · The paper itself

Abstract

backgroundEvidence suggests that semi-facial respirators provide protection against contamination in high-risk environments, although the COVID-19 pandemic called for greater protection and viral inactivation capacity. Thus, the aim of this study was to investigate the efficacy of a novel semi-facial respirator containing chitosan nanoparticles, compared with a conventional N95 respirator on the incidence of laboratory-confirmed SARS-CoV-2 in healthcare professionals. The secondary outcomes were influenza infection, usability and comfort.

methodsRandomized controlled trial within a large public hospital (reference for COVID-19 patients) carried out between March 2021 and June 2023. We included 230 healthcare professionals exposed to SARS-Cov-2 and influenza, working in emergency departments, hospital wards, and intensive care units. Participants were assessed at baseline, after 10 days, and 21 days of follow-up. Researchers, participants, and outcome assessors were blinded to the allocated groups. Outcomes were analyzed by bivariate and multivariate comparisons using logistic regression. Crude (cOR) and adjusted odds ratios (aOR) were estimated, followed by 95% confidence intervals (CIs 95%). We adopted intention-to-treat (ITT) and complete-case (CC) analyses.

resultsBaseline characteristics were considered homogeneous between groups, and usability and comfort were reported as excellent in both groups. Non-significant differences were found for all outcomes, both in the ITT and CC analyses. The incidence of COVID-19 and influenza were, respectively, cOR: 0.96 [CI95%: 0.21-4.42] and cOR: 1.25 [CI95%: 0.34-4.62]; and aOR: 1.08 [CI95%: 0.21-5.47] and aOR: 1.11 [CI95%: 0.17-7.01].

conclusionsWe found that the incidence of SARS-Cov-2 and influenza infections were similar between the new respirator compared to the conventional respirator. Furthermore, we observed that usability and comfort were similar and considered excellent for both respirators.

trial registrationClinicaltrials.gov (NCT04490200, 29/07/2020).

Indexed as

ChitosanCOVID-19Health PersonnelNanoparticlesSARS-CoV-2AdultFeasibility StudiesFemaleHumansIncidenceInfluenza, HumanMaleMiddle AgedN95 RespiratorsRespiratory Protective DevicesChitosanCOVID-19Healthcare professionalsPersonal protective equipmentPublic health

Identifiers

PMID39333902
PMCPMC11429083

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

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.