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New Reusable Mask Design With Superior Filtration and Fit

Primary Purpose

Covid19, Tuberculosis, Respiratory Viral Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
N95 mask
Nordell single E-100 layer mask
Nordell double E-100 layer mask
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring PPE, mask, N95, pandemic, mask shortage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic Health System in Mankato

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health care workers

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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)
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)

Secondary Outcome Measures

Full Information

First Posted
March 18, 2021
Last Updated
June 15, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04826809
Brief Title
New Reusable Mask Design With Superior Filtration and Fit
Official Title
A New Fully-reusable, Affordable, Comfortable Mask Design With Superior Filtration and Fit for Use During Respirator Shortages and Pandemics
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
October 27, 2022 (Actual)
Study Completion Date
October 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Tuberculosis, Respiratory Viral Infection
Keywords
PPE, mask, N95, pandemic, mask shortage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health care workers
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
N95 mask
Intervention Description
Standard 1870 N95 one time use mask
Intervention Type
Device
Intervention Name(s)
Nordell single E-100 layer mask
Intervention Description
Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay
Intervention Type
Device
Intervention Name(s)
Nordell double E-100 layer mask
Intervention Description
Nordell mask design using two layers of E-100 fabric
Primary Outcome Measure Information:
Title
Comparison of Fit Tests
Description
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
Title
Comfort Level of Nordell Double E-100 Layer Mask
Description
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
Title
Ability to Breathe With Nordell Double E-100 Layer Mask
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janielle R Nordell, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Health System in Mankato
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56001
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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New Reusable Mask Design With Superior Filtration and Fit

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