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Clinical Trial on the Efficacy of Different Masks With and Without a Peripheral Sealing Device, Against Covid-19

NCT05079308 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2021-10-26

No results posted yet for this study

Summary

A significant number of professionals subjected to high-risk situations have been infected by Covid-19, due to the lack of adequate respiratory protection equipment or poor marginal sealing adjustments. Then, the objective of this study is to determine if there are statistically significant differences in the level of respiratory protection of type IIR surgical face masks and filtering face masks, used with and without a peripheral sealing device, against the contagion of Covid-19 or other harmful biological agents. The proposed device is a thermoplastic resin ring composed of a reusable and biodegradable polylactic acid designed to be used in a healthcare environment. The individuals of the study will be submitted to qualitative fit tests, that meet current Ocupational Security and Health Administration (OSHA) standard. The mentioned qualitative fit test uses a sodium saccharin solution to evaluate the respiratory protection equipment in professionals in hospitals, emergency centers, and early childhood education centers.

Conditions

  • Covid19
  • Personal Protective Equipment

Interventions

DEVICE

Peripheral sealing device for surgical mask or filtering face piece

The individuals used a Peripheral Sealing Device on a surgical mask or a filtering face piece mask and were submitted to a qualitative fit test, regulated by the Occupational Security and Health Administration (USA).

DEVICE

IIR Surgical mask with Filtering face piece

The individuals used a IIR surgical mask with a filtering face piece mask and were submitted to a qualitative fit test, regulated by the Occupational Security and Health Administration (USA).

Sponsors & Collaborators

  • University of the Balearic Islands

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-06-30
Completion
2021-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05079308 on ClinicalTrials.gov