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

Covid19 Clinical Trial

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:

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749121
• Other study ID #: 059/63
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: February 5, 2021

Study information

• Verified date: February 2021
• Source: Bangkok Metropolitan Administration Medical College and Vajira Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 5, 2021
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

Healthy volunteers 18 to 60 years old.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Covid19

Intervention

Device:
• UVC Irradiation
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.

Drug:
• UVC Irradiation
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.

Device:
• Fit test
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 strength
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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine ,Vajira hospital,Navamindradhiraj University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Bangkok Metropolitan Administration Medical College and Vajira Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fit test	The percent of participants that passed the fit test after UVC decontamination	3 days
Primary	Colony count of microorganisms	Colony count of virus ,bacteria and fungus after UVC and alcohol decontamination	2 weeks
Primary	Load of Tensile strength	Measure tensile strength and elengation at break after UVC irradiation (Millipascal)	2 weeks