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Ultraviolet Germicidal Irradiation on the New Silicone Half-Piece Elastometric Respirators

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
UVC Irradiation
UVC Irradiation
Fit test
Tensile strength
Sponsored by
Bangkok Metropolitan Administration Medical College and Vajira Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring COVID-19, Decontamination, Filtering facepiece respirators, UVC

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy volunteers 18 to 60 years old.

Exclusion Criteria:

  • contraindications to fit test, such as asthma, congestive heart failure, anosmia, and ageusia.

Sites / Locations

  • Faculty of Medicine ,Vajira hospital,Navamindradhiraj University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fit test

Arm Description

All the participants had to pass the initial fit test.After decontamination with UVC irradiation for 60 minutes.The protocol was conducted in accordance with the protocol from the OSHA respiratory protection standard , including the number, type, and duration of the exercise, and the seal checks in accordance with the manufacturer's instructions[15] 60 minutes, fit testing was conducted using qualitative fit test (Bittrex Solution aerosol)

Outcomes

Primary Outcome Measures

Fit test
The percent of participants that passed the fit test after UVC decontamination
Colony count of microorganisms
Colony count of virus ,bacteria and fungus after UVC and alcohol decontamination
Load of Tensile strength
Measure tensile strength and elengation at break after UVC irradiation (Millipascal)

Secondary Outcome Measures

Full Information

First Posted
February 4, 2021
Last Updated
February 9, 2021
Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04749121
Brief Title
Ultraviolet Germicidal Irradiation on the New Silicone Half-Piece Elastometric Respirators
Official Title
Impact of Ultraviolet Germicidal Irradiation on the New Silicone Half-Piece Elastometric Respirators (VJR-NMU) Respirator Performances, Structural Integrity and Sterility During COVID -19 Pandemic:
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
February 5, 2021 (Actual)
Study Completion Date
February 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital

4. Oversight

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

5. Study Description

Brief Summary
Since the innovation of our new half- elastometric half-piece respirator, this type of FFR has been used widely in our country. Decontamination methods including ultraviolet C (UVC) germicidal irradiation and 70% alcohol have been implemented to decontaminate the respirator. We than examined inactivation potential for the Porcine epidemic diarrhea virus (PEDV), numerous bacterial strains ,mostly skin-derived after the decontamination process.To enable rigorous integrity after repeated decontamination process, fit test by the Bitrex test ,tensile strength and elongation at break were also evaluated. Our results showed that the UVC at the dose of 3 J/cm2 can eradicate the bacteria at 60 min and virus at 10 min.No fungus was found on the mask surface at the beginning. Good Fit test , tensile strength and elongation at break were still main maintained after multiple cycles of decontamination. No evidence of physical degradation by gross visual inspection was found. 70% alcohol is also an easy and effective way to eradicate microorganisms on the mask.As the current pandemic is expected to continue for months to years, the need to supply adequate reserves of PPE and develop effective reprocessing is crucial. Our studies demonstrated that the novel silicone mask can be safely reprocessed and decontaminated for many cycles by UVC irradiation and help restore the shortage of the important protective devices in the COVID-19 pandemic era.
Detailed Description
this study showed that UVC irradiation at the dosage 300 uWatt-sec/cm2 for 1 minute satisfactorily decontaminated the silicone mask as measured by viral culture. The timing to eradicate bacteria was 60 minutes longer due to the tolerability of the bacteria .70% alcohol effectively decontaminate the virus and bacteria deposited on the masks and filters. Good level of fit can be maintained following UVC treatment. The tensile strength of the strap was retained over multiple decontamination cycles using UVC and dry heat upto 60 cycles.Given the efficacy of the disinfection by UVC and 70 % alcohol ,these types of decontamination method could potentially be used for the new type of silicone masks half-piece respirator in the setting of a crisis with inadequate supplies of PPE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19, Decontamination, Filtering facepiece respirators, UVC

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Before and after intervention in one group
Masking
None (Open Label)
Masking Description
The participants will be tested for fit test before and after UVC determination of the respirators.The other tests were in vitro and based on the survival of bacteria and virus on the masks together with the tensile strength
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fit test
Arm Type
Experimental
Arm Description
All the participants had to pass the initial fit test.After decontamination with UVC irradiation for 60 minutes.The protocol was conducted in accordance with the protocol from the OSHA respiratory protection standard , including the number, type, and duration of the exercise, and the seal checks in accordance with the manufacturer's instructions[15] 60 minutes, fit testing was conducted using qualitative fit test (Bittrex Solution aerosol)
Intervention Type
Device
Intervention Name(s)
UVC Irradiation
Intervention Description
We used the Porcine epidemic diarrhea virus (PEDV) as the indicator virus .An N99 mask was contaminated by spraying or applying with the virus on the exterior and interior surface of each silicone mask. Also, 100 μl of the viral suspension was spotted onto the filter part of N99 masks. Following 20-30 minutes of drying, the silicone masks underwent each of the decontamination procedures which are ultraviolet-C (UV-C) irradiation and 70% alcohol treatment. For UV irradiation, N99 masks were placed in an UV-C incubator ) and were exposed for different times at 1, 10 and 20 minutes, respectively.Untreated control and treated N99 masks were analyzed for viral infectivity in VERO cell cultures. At 48 hours post-infection, cells were examined for evaluation the viral infectivity via observation of cytopathic effect. Results for each treatment express mean ± standard deviations of 3 biological replicates.
Intervention Type
Drug
Intervention Name(s)
UVC Irradiation
Intervention Description
Bacterial and fungal sampling were obtained from the inside and outside surface areas likely to the frequently touched and close contact with the face of hospital personnel. The cultures were then isolated onto the blood agars and Mac Conkey agars, respectively. After incubation, the total number of bacterial and fungal colonies were counted, recorded, and selected different colonies.
Intervention Type
Device
Intervention Name(s)
Fit test
Intervention Description
All the participants had to pass the initial fit test.After decontamination with UVC irradiation for 60 minutes, fit testing was conducted using qualitative fit test (Bittrex Solution aerosol),
Intervention Type
Device
Intervention Name(s)
Tensile strength
Intervention Description
We measured the tensile strength of the strap of the Silicone mask before and after the UVC irradiation to study the strength and reliliency of the strap
Primary Outcome Measure Information:
Title
Fit test
Description
The percent of participants that passed the fit test after UVC decontamination
Time Frame
3 days
Title
Colony count of microorganisms
Description
Colony count of virus ,bacteria and fungus after UVC and alcohol decontamination
Time Frame
2 weeks
Title
Load of Tensile strength
Description
Measure tensile strength and elengation at break after UVC irradiation (Millipascal)
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers 18 to 60 years old. Exclusion Criteria: contraindications to fit test, such as asthma, congestive heart failure, anosmia, and ageusia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thananda Trakarnvanich
Organizational Affiliation
Bangkok Metropolitan Administration and Vajira Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine ,Vajira hospital,Navamindradhiraj University
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Plan to share in protocol.io

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Ultraviolet Germicidal Irradiation on the New Silicone Half-Piece Elastometric Respirators

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