New Reusable Mask Design With Superior Filtration and Fit

NCT ID: NCT04826809

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-09
• Study Completion Date: 2022-10-27

Brief Summary

This study will test the filtration, air leak, and breathability of a newly designed fully washable mask developed by Dr. Nordell with the Mayo Clinic. This mask is theorized to be a superior alternative to other respirators currently used when one-time-use N95 masks are unavailable.

Detailed Description

The purpose of this study is to determine potential effectiveness of a new, reusable mask against SARS-CoV-2 and other microbes. This requires filtering down to at least 0.3 microns, as the SARS-CoV-2 virus is on average 0.25-0.5 microns in diameter.

Dr. Nordell has developed a machine-washable mask which shows potential to be significantly more effective than other masks on the market. It uses a fabric that is machine washable, without need for a filter or replaceable component. This fabric, Evolon-100 or E-100, is a microfilament fabric produced by a private company outside of the USA (and is therefore not yet FDA approved as of December 2020).

Unofficial data shows this mask passes the "N95 fit test" before and after multiple washes on the majority of individuals tested, and the material used in Dr. Nordell's design filters 93-96% of 0.3 micron particles. For reference, the N95 mask used in the hospital (whenever concern for potential exposure to COVID-19 or similar contagion exists) filters 95% of 0.3 micron particles when factoring in air leak, assessed with the "fit test." Voluntary survey of users also shows it is more comfortable than other masks, including the N95. This mask is also reported to be breathable even after prolonged use.

This mask design addresses every factor in respirator design. The design intentionally uses pleats to increase the effective mask surface area while decreasing the seal perimeter, resulting in increased air flow, lower pressure drop, and increased filtration efficiency. The investigators propose that it has a higher filtration ability than other washable fabrics tested, filtering at least 93% of 0.3 micron particles, even up to 96%. It also helps prevent air leak, a large factor limiting efficacy of most non-standard masks. It is easy to don and doff, and it is very easy to clean and disinfect. This material can be washed multiple times in a standard washing machine without reducing its effectiveness. And finally, it is very affordable, with materials for one mask costing less than $1.50. All materials used beyond this specific fabric are easily purchased on the internet or in a fabric store.

Upon completion of this research, the investigators hope to demonstrate that this mask is a superior alternative in multiple settings, including hospitals in developing countries with little or no N95 mask access, non-hospital settings such as businesses and schools, as well as for the general population, especially those with high risk for COVID-related complications.

Conditions

Covid19; Tuberculosis; Respiratory Viral Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Health care workers

Health care workers will complete a fit test while wearing the Nordell Single E-100 layer + (cotton layer) mask, Nordell Double E-100 layer mask and an N95 mask

Group Type: EXPERIMENTAL

N95 mask

Intervention Type: DEVICE

Standard 1870 N95 one time use mask

Nordell single E-100 layer mask

Intervention Type: DEVICE

Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay

Nordell double E-100 layer mask

Intervention Type: DEVICE

Nordell mask design using two layers of E-100 fabric

Interventions

N95 mask

Standard 1870 N95 one time use mask

Intervention Type: DEVICE

Nordell single E-100 layer mask

Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay

Intervention Type: DEVICE

Nordell double E-100 layer mask

Nordell mask design using two layers of E-100 fabric

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Current employee of Mayo Clinic Health System-Mankato
• Passed N95 fit test within the past year
• No medical history of: high blood pressure, current or recent pneumonia or upper respiratory infection, and no uncontrolled chronic asthma
• Ideally with wide representation of genders, race, age, BMI, occupation/role in hospital.
• Willing and able to provde verbal consent.

Exclusion Criteria

• History of uncontrolled asthma, pneumonia, or hypertension.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Janielle R. Nordell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janielle R Nordell, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Health System in Mankato

Mankato, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

20-011897

Identifier Type: -

Identifier Source: org_study_id