NCT05008627

PERSONAL PROTECTION EQUIPMENT AND SARS-CoV-2 CONTAMINATION

Completed Last updated 27 April 2022

What this trial tests

trial in Contaminated Medical or Biological Substances in 49 participants. Completed in 31 December 2021.

Timeline

15 July 2021

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Bnai Zion Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	49
Start date	15 July 2021
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across Israel

Conditions studied

• Contaminated Medical or Biological Substances — all drugs for Contaminated Medical or Biological Substances →

Sponsor

Bnai Zion Medical Center

Who can join

Adults 20 to 65, any sex, with Contaminated Medical or Biological Substances. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings.
   Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, et al · · 2022 · cited 17× · PMID 35514111 · DOI 10.1002/14651858.cd015112.pub2
2. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings.
   Constantin AM, Noertjojo K, Sommer I, Pizarro AB, et al · · 2024 · cited 2× · PMID 38597249 · DOI 10.1002/14651858.cd015112.pub3
3. Removal of Contaminated Personal Protective Equipment With and Without Supervision. A Randomized Crossover Simulation-Based Study.
   Somri M, Hochman O, Somri-Gannam L, Gaitini L, et al · · 2024 · cited 1× · PMID 37185879 · DOI 10.1097/sih.0000000000000726