New Reusable Mask Design With Superior Filtration and Fit

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04826809

Collaborator

(none)

Enrollment

Location

Arm

19.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Tuberculosis Respiratory Viral Infection	Device: N95 mask Device: Nordell single E-100 layer mask Device: Nordell double E-100 layer mask	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A New Fully-reusable, Affordable, Comfortable Mask Design With Superior Filtration and Fit for Use During Respirator Shortages and Pandemics

Actual Study Start Date :

Apr 9, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: N95 mask Standard 1870 N95 one time use mask Device: Nordell single E-100 layer mask Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay Device: Nordell double E-100 layer mask Nordell mask design using two layers of E-100 fabric

Arm

Intervention/Treatment

Experimental: 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

Device: N95 mask

Standard 1870 N95 one time use mask

Device: Nordell single E-100 layer mask

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

Device: Nordell double E-100 layer mask

Nordell mask design using two layers of E-100 fabric

Outcome Measures

Primary Outcome Measures

Filter rate [6 months]
The percentage of particles that are 0.3 microns in size or larger
Comfort level [6 months]
Measured by a self-reported questionnaire that rates the comfort level of the new mask on a scale from 0 to 5 (0 is the most uncomfortable mask ever worn, 5 is the best, most comfortable mask)
Ability to breathe [6 months]
Measured by a self-reported questionnaire that rates ability to breathe comfortably while wearing the new mask, from 0 (not able to breathe at all) to 5 (just as easy to breathe as not wearing any mask)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.