PERSONAL PROTECTION EQUIPMENT AND SARS-CoV-2 CONTAMINATION

NCT05008627 | Completed DMC

• 1 other identifier: 0059-21-BNZ
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Contaminated Medical or Biological Substances

Keywords

VIRAL CONTAMINATION; DOFFING PPE; GUIDELINES FOR DOFFING

Outcome Measures

Primary Outcomes (1)

• Contamination with simulated virus

  Quality control observation

  15 minutes

Study Arms (2)

Doffing PPE with verbal instructions and monitor

The subject will remove the PPE according to verbal instructions by a monitor

Doffing PPE without verbal instructions

The subject will remove the PPE independently without a monitor

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Staff members of the CORONA UNIT

You may qualify if:

• Age limit
• Staff members who worked in CORONA UNIT

You may not qualify if:

• Staff members who did not work in CORONA UNIT

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

Bnai Zion Medical Center

Haifa, Israel

Location

Study Officials

• Mostafa Somri, MD

  Bnai Zion Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor of Anesthesiology

Study Record Dates

• First Submitted: August 15, 2021
• First Posted: August 17, 2021
• Study Start: July 15, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

IL (1)