- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04749121
Ultraviolet Germicidal Irradiation on the New Silicone Half-Piece Elastometric Respirators
February 9, 2021 updated by: Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
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:
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bangkok, Thailand, 10300
- Faculty of Medicine ,Vajira hospital,Navamindradhiraj University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Healthy volunteers 18 to 60 years old.
Exclusion Criteria:
- contraindications to fit test, such as asthma, congestive heart failure, anosmia, and ageusia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Fit test
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)
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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.
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.
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),
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fit test
Time Frame: 3 days
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The percent of participants that passed the fit test after UVC decontamination
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3 days
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Colony count of microorganisms
Time Frame: 2 weeks
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Colony count of virus ,bacteria and fungus after UVC and alcohol decontamination
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2 weeks
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Load of Tensile strength
Time Frame: 2 weeks
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Measure tensile strength and elengation at break after UVC irradiation (Millipascal)
|
2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thananda Trakarnvanich, Bangkok Metropolitan Administration and Vajira Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2020
Primary Completion (ACTUAL)
February 5, 2021
Study Completion (ACTUAL)
February 5, 2021
Study Registration Dates
First Submitted
February 4, 2021
First Submitted That Met QC Criteria
February 9, 2021
First Posted (ACTUAL)
February 11, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 11, 2021
Last Update Submitted That Met QC Criteria
February 9, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 059/63
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Plan to share in protocol.io
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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