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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Drug: UVC Irradiation; Device: Fit test; Device: Tensile strength

• Registration Number: NCT04749121
• Lead Sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital

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.

Study Timeline

• Study Start: 2020-04-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-04
• Primary Completion: 2021-02-05
• Study Completion: 2021-02-05
• Study First Submitted QC: 2021-02-09
• Last Update Submitted: 2021-02-09
• Study First Posted: 2021-02-11
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Fit test	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)
Fit test	Tensile strength	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)
Fit test	UVC Irradiation	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)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine ,Vajira hospital,Navamindradhiraj University; 🇹🇭 Bangkok, Thailand