PERSONAL PROTECTION EQUIPMENT AND SARS-CoV-2 CONTAMINATION
Condition: Contaminated Medical or Biological Substances
Study type: Observational

Summary: 
      Transmission of SARS-CoV-2 occurs through common routes, aerosols and medical procedure.

      Personal protective equipment (PPE) reduces the risk of contamination. The risk of
      contamination of skin and clothing may be particularly high during removal PPE.

      The Ministry of Health (MOH) of Israel adapted the technique of using a supervisor that
      monitors during removal of the PPE.

      The aim of this study to examine the using the pre-established protocol, where a staff member
      removing the PPE according supervision by a staff monitor in comparison with removing the PPE
      without being instructed neither supervised.

      The Protocol provided by MOH is in accordance with the recommendations of the Centers for
      Disease Control United States (CDC), was presented to all staff.

      Study population will include 49 participants: 7 nurses, 7 clinician physicians, 7 cleaning
      personal, 7 X-rays technicians, 7 anesthesia technician and 7 physiotherapists 7 stretcher
      bearers, will performed this quality control observational study.

      The trail processes of doffing the PPE will be performed twice, first in the present of a
      trained supervisor and verbal instructions and once again independently in the absence of
      supervision.

      After donning the routine uniform with a new PPE, then the subject will be asked to transfer
      to an area were the participant's' PPE will be "contaminated" (in the same areas in all
      participants: over the thorax, shoulders, arms, hands legs and Face Shield) using a brush
      tool, with the 'Glo' Germ Solution that simulates contamination with a virus on the PPE. The
      'Glo' Germ Solution is a non toxic, odorless gel, which glows brightly in the dark when
      exposed to ultraviolet light to simulate contamination with the virus.

      To proceed, the participant will be asked to move a step aside to another area. There the
      participant will remove the PPE.

      After the removal of the PPE the participant will be examined in a dark plot in order to
      detect a probably contamination traces with the 'Glo' Germ solution that will be illuminated
      under the ultraviolet UV light.

      The participant will repeat the procedure from the beginning, following all stages only in
      this second time without following the supervisor verbal instructions.

      In both trails, after the PPE removal, Ultraviolet Lamp will be used in order to check if the
      participant had been contaminated in any part of the body or cloth with the 'Glo' Germ
      Solution
    

Detailed description: 
      PERSONAL PROTECTION EQUIPMENT AND SARS-CoV-2 CONTAMINATION: An observational quality control
      study Human-to-human transmission of SARS-CoV-2 (COVID-19) occurs through common routes such
      as direct transmission, contact transmission and airborne transmissions as aerosols and
      during medical procedure.

      Personal protective equipment (PPE) reduces, but does not eliminate, the risk of skin and
      clothing contamination with a virus among health care personnel. High-risk exposures, such as
      prolonged exposure, handling contaminated body fluids, and failure to correctly use PPE,
      increases the risk of contamination.

      The risk of inadvertent contamination of skin and clothing may be particularly high during
      removal of contaminated PPE.

      It was presented that during PPE removal, the subject, especially the dorsum of his hands,
      were contaminated and virus was transferred to the palms hands and clothing.

      Operating protocols recommended by the Centers for Disease Control and Prevention (CDC) have
      been associated with less frequent hand and clothing contamination compared with no
      standardized methods, suggesting that the use of the appropriate technique can reduce
      contamination. Another potential measure to reduce contamination during PPE removal is in the
      present of a trained supervisor monitoring each step of the removal process, as has been
      recommended when caring for patients with suspected or confirmed Ebola virus infection.

      The Ministry of Health (MOH) of Israel adapted the technique of using a supervisor to guide
      the medical personal that work in the Covid Unit during donning and doffing the PPE.

      A quality controlled observational study will be performed to examine if using visual
      vigilance control and verbal oral instructions to remove the contaminated PPE, in an
      appropriate technique, that prevents or reduces contamination during the procedure, in
      comparison with performing the removal of the PPE independently without visual control and
      verbal instructions by in the absence of supervisor.

      The aim of this study to examine the using the pre-established protocol, where a staff member
      removing the PPE according to the visual supervision by a staff monitor and follows the
      instructions carefully, in comparison with the removing the PPE without being instructed
      neither supervised.

      The study received the approval of the Bnai-Zion Medical Center, Haifa, Israel, Ethic
      Committee No 0059-21-BNZ.

      Statistical Analysis A 1% of contamination will be considered as an acceptable level and 10%
      of contamination as a non-acceptable level. To detect such deviation from the acceptable
      level in a Z-test on the proportion of contamination with 95% power and one-sided α of 0.05,
      34 participants be required.

      Materials and Methods Before opening of the Corona Unit at the Hospital, the Infected Disease
      Department provided educational sessions for personnel from long term care facility. The
      session included 15 minutes video presentation and practicing of PPE donning and doffing
      technique.

      The protocol provided by the MOH according with CDC recommendations was presented to all
      staff. A poster highlighting the instructions was displayed throughout the Corona Unit. Based
      on national recommendations, a checklist including 10 instructions (See Appendix 1) were
      compiled, it contained items to assess the processes of doffing of the PPE with the necessary
      work steps such as the required of hand disinfection. The Protocol includes additional
      measures to reduce contamination, during PPE removal. A trained supervisor was observing and
      giving verbal indication of each step of the removal process. This strategy was used during
      Ebola epidemic.

      The present simulation study will be conducted in the Simulation Unit of the Anesthesiology
      Department in Bnai Zion Medical Center, Haifa, Israel.

      Study population will include 49 participants: 7 nurses, 7 clinician physicians, 7 cleaning
      personal, 7 X-rays technicians, 7 anesthesia technician and 7 physiotherapists 7 stretcher
      bearers will performed this quality control observational study.

      The trail processes of donning the PPE will be performed twice, first with the present of a
      trained supervisor and verbal instructions and once again independently in the absence of
      supervision.

      The experiment will be conducted in 3 areas, namely, area A (clean zone), area B (preparation
      zone), and area C (test zone).

      Area A, a clean zone where subjects will donn their clean isolation gown or apron by
      themselves.

      After putting on over the routine uniform a new PPE (Cobes Industries Co Ltd, Hefei, China)
      gown or apron, NP95 Mask and a face shield, the subject then will be asked to transfer to
      area B, there participant's' PPE will be "contaminated" in the same areas in all
      participants: over the thorax, shoulders, arms, hands legs and Face Shield using a brush
      tool, with the Glo Germ Solution (Glo Germ Lotion, Glo Germ, Moab, Utah, USA) that simulates
      contamination with a virus on the PPE. The Glo Germ Solution is a non toxic, odorless gel,
      which glows brightly in the dark when exposed to ultraviolet light to simulate contamination
      with the virus, including transfer to skin, clothing, and environmental surfaces during PPE
      removal. (www.amazon.com/Glo Germ-Powder solution).

      To proceed, the participant will be asked to move a step aside to area C. There the
      participant will remove the PPE, boats, the apron, mask NP95 and face shield according the
      pre-established Protocol under an oral indications by the research staff following the 10
      guidance instructions.

      The contaminated PPE equipment will be discarded in a dumpster. After the removal of the PPE
      the participant will be examined in a dark plot in order to detect a probably contamination
      traces with the Glo Germ solution that will be illuminated under the ultraviolet UV light.

      The participant will repeat the procedure, following all stages only in the second time
      without the following the supervisor verbal instructions.

      In both trails, after the PPE removal, Ultraviolet Lamp will be used in order to check if the
      participant had been contaminated in any part of the body or cloth with the Glo Germ
      Solution.

      All the procedures will be recorded with a I-Phone 8 camera during all the time of the
      procedure.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Staff members of the CORONA UNIT
      
Keywords: VIRAL CONTAMINATION; DOFFING PPE; GUIDELINES FOR DOFFING