Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05008627 |
| Other study ID # |
0059-21-BNZ |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 15, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
Bnai Zion Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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.
