Covid19NCT04749121
Ultraviolet Germicidal Irradiation on the New Silicone Half-Piece Elastometric Respirators
A study testing UVC Irradiation, Fit test and Tensile strength in people with Covid19, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- UVC Irradiation, Fit test and Tensile strength
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2020to 5 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers 18 to 60 years old.
Who cannot join
- contraindications to fit test, such as asthma, congestive heart failure, anosmia, and ageusia.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine ,Vajira hospital,Navamindradhiraj University
Bangkok, 10300
About this study
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:
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- UVC Irradiation, Fit test, Tensile strength
- Keywords
- COVID-19, Decontamination, Filtering facepiece respirators, UVC
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVC IrradiationDevice
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.
UVC IrradiationDrug
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.
Fit testDevice
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),
Tensile strengthDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Fit test | Experimental | 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) Receives: Device: UVC Irradiation; Drug: UVC Irradiation; Device: Fit test; Device: Tensile strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fit test
The percent of participants that passed the fit test after UVC decontamination
Measured: 3 days
Colony count of microorganisms
Colony count of virus ,bacteria and fungus after UVC and alcohol decontamination
Measured: 2 weeks
Load of Tensile strength
Measure tensile strength and elengation at break after UVC irradiation (Millipascal)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Apr 2020
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Before and after intervention in one group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Investigators
- Thananda Trakarnvanich, Principal investigator, Bangkok Metropolitan Administration and Vajira Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749121
- Sponsor's protocol ID
- 059/63
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan to share in protocol.io
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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:
- ClinicalTrials.gov ID
- NCT04749121
- Acronym / sponsor ID
- 059/63
- Conditions
- Covid19
- Keywords
- COVID-19, Decontamination, Filtering facepiece respirators, UVC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira HospitalOther government
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and after intervention in one group
| Arm | Type | Receives |
|---|---|---|
| Fit test | Experimental | Device: UVC Irradiation, Drug: UVC Irradiation, Device: Fit test, Device: Tensile strengthAll 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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers 18 to 60 years old.
Key exclusion criteria (1 listed)
- contraindications to fit test, such as asthma, congestive heart failure, anosmia, and ageusia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UVC IrradiationWe 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. | Device | Fit test |
| UVC IrradiationBacterial 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. | Drug | Fit test |
| Fit testAll 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), | Device | Fit test |
| Tensile strengthWe 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 | Device | Fit test |
Primary outcome
Fit test
Time frame: 3 days
The percent of participants that passed the fit test after UVC decontamination
Colony count of microorganisms
Time frame: 2 weeks
Colony count of virus ,bacteria and fungus after UVC and alcohol decontamination
Load of Tensile strength
Time frame: 2 weeks
Measure tensile strength and elengation at break after UVC irradiation (Millipascal)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- 5\. Centers for Disease Control and Prevention. Decontamination and reuse of filtering facepiece respiratorsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Plan to share in protocol.io
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thananda Trakarnvanich principal investigator
Bangkok Metropolitan Administration and Vajira Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UVC Irradiation, Fit test and Tensile strength in people with Covid19, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fit test (time frame: 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.