Clinical trial NCT04749121: 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
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: COVID-19
Decontamination
Filtering facepiece respirators
UVC
Lead sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Before and after intervention in one group
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Fit test
timeFrame: 3 days
measure: Colony count of microorganisms
timeFrame: 2 weeks
measure: Load of Tensile strength
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine ,Vajira hospital,Navamindradhiraj University
Study officials:
affiliation: Bangkok Metropolitan Administration and Vajira Hospital
name: Thananda Trakarnvanich
role: PRINCIPAL_INVESTIGATOR
References: