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New Reusable Mask Design With Superior Filtration and Fit

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04826809
Enrollment
41
Registered
2021-04-01
Start date
2021-04-09
Completion date
2022-10-27
Last updated
2023-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Respiratory Viral Infection, Tuberculosis

Keywords

PPE, mask, N95, pandemic, mask shortage

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.

Interventions

DEVICEN95 mask

Standard 1870 N95 one time use mask

DEVICENordell single E-100 layer mask

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

DEVICENordell double E-100 layer mask

Nordell mask design using two layers of E-100 fabric

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Exclusion criteria

\- History of uncontrolled asthma, pneumonia, or hypertension.

Design outcomes

Primary

MeasureTime frameDescription
Comparison of Fit TestsBaselineNumber of participants to pass the respirator fit testing using Bitrix solution. If participants do not smell or taste the solution while wearing the respirator it is considered passed.
Comfort Level of Nordell Double E-100 Layer MaskBaselineMeasured by a self-reported questionnaire that rates the comfort level of the Nordell Double E-100 layer 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 With Nordell Double E-100 Layer MaskBaselineMeasured by a self-reported questionnaire that rates ability to breathe comfortably while wearing the Nordell Double E-100 Layer Mask, from 0 (not able to breathe at all) to 5 (just as easy to breathe as not wearing any mask)

Countries

United States

Participant flow

Participants by arm

ArmCount
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 N95 mask: Standard 1870 N95 one time use mask Nordell single E-100 layer mask: Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay Nordell double E-100 layer mask: Nordell mask design using two layers of E-100 fabric
41
Total41

Baseline characteristics

CharacteristicHealth Care Workers
Age, Customized
>= 60 years
4 Participants
Age, Customized
Between 18 and 29 years
3 Participants
Age, Customized
Between 30 and 39 years
15 Participants
Age, Customized
Between 40 and 49 years
11 Participants
Age, Customized
Between 50 and 59 years
8 Participants
Race/Ethnicity, Customized
American Indian
0 Participants
Race/Ethnicity, Customized
Asian/Pacific Islander
2 Participants
Race/Ethnicity, Customized
Black/African American
0 Participants
Race/Ethnicity, Customized
Hispanic
2 Participants
Race/Ethnicity, Customized
Other
0 Participants
Race/Ethnicity, Customized
White, non-Hispanic
37 Participants
Region of Enrollment
United States
41 participants
Sex: Female, Male
Female
34 Participants
Sex: Female, Male
Male
7 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 41
other
Total, other adverse events
0 / 41
serious
Total, serious adverse events
0 / 41

Outcome results

Primary

Ability to Breathe With Nordell Double E-100 Layer Mask

Measured by a self-reported questionnaire that rates ability to breathe comfortably while wearing the Nordell Double E-100 Layer Mask, from 0 (not able to breathe at all) to 5 (just as easy to breathe as not wearing any mask)

Time frame: Baseline

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Health Care WorkersAbility to Breathe With Nordell Double E-100 Layer Mask0 (worst)0 Participants
Health Care WorkersAbility to Breathe With Nordell Double E-100 Layer Mask10 Participants
Health Care WorkersAbility to Breathe With Nordell Double E-100 Layer Mask21 Participants
Health Care WorkersAbility to Breathe With Nordell Double E-100 Layer Mask34 Participants
Health Care WorkersAbility to Breathe With Nordell Double E-100 Layer Mask411 Participants
Health Care WorkersAbility to Breathe With Nordell Double E-100 Layer Mask5 (best)25 Participants
Primary

Comfort Level of Nordell Double E-100 Layer Mask

Measured by a self-reported questionnaire that rates the comfort level of the Nordell Double E-100 layer mask on a scale from 0 to 5 (0 is the most uncomfortable mask ever worn, 5 is the best, most comfortable mask)

Time frame: Baseline

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Health Care WorkersComfort Level of Nordell Double E-100 Layer Mask0 = most uncomfortable0 Participants
Health Care WorkersComfort Level of Nordell Double E-100 Layer Mask11 Participants
Health Care WorkersComfort Level of Nordell Double E-100 Layer Mask20 Participants
Health Care WorkersComfort Level of Nordell Double E-100 Layer Mask34 Participants
Health Care WorkersComfort Level of Nordell Double E-100 Layer Mask422 Participants
Health Care WorkersComfort Level of Nordell Double E-100 Layer Mask5 = most comfortable14 Participants
Primary

Comparison of Fit Tests

Number of participants to pass the respirator fit testing using Bitrix solution. If participants do not smell or taste the solution while wearing the respirator it is considered passed.

Time frame: Baseline

Population: One participant was excluded from analysis of this outcome measure due to recent viral illness

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Health Care WorkersComparison of Fit TestsFit Test N9539 Participants
Health Care WorkersComparison of Fit TestsFit Test Nordell Single Layer Mask39 Participants
Health Care WorkersComparison of Fit TestsFit Test Nordell Double Layer Mask40 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026