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Contaminated Medical or Biological SubstancesNCT05008627

PERSONAL PROTECTION EQUIPMENT AND SARS-CoV-2 CONTAMINATION

An observational study of Contaminated Medical or Biological Substances, run by Bnai Zion Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
How many people
49 participants
Where
1 siteIsrael
Study dates
15 Jul 2021to 31 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Staff members of the CORONA UNIT

Who may be able to join

  • Age limit
  • Staff members who worked in CORONA UNIT

Who cannot join

  • Staff members who did not work in CORONA UNIT

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Bnai Zion Medical Center

    Haifa

Other trials in Israel

About this study

Official title: PERSONAL PROTECTION EQUIPMENT AND SARS-CoV-2 CONTAMINATION: An Observational Quality Control Study

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.

Read more

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

Read the 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.

Keywords
VIRAL CONTAMINATION, DOFFING PPE, GUIDELINES FOR DOFFING

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05008627
Study groupRoleWhat they receive
Doffing PPE with verbal instructions and monitorThe subject will remove the PPE according to verbal instructions by a monitor
Doffing PPE without verbal instructionsThe subject will remove the PPE independently without a monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Contamination with simulated virus

    Quality control observation

    Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2021
  2. Study start15 Jul 2021
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05008627
Sponsor's protocol ID
0059-21-BNZ
Status last verified
Apr 2022
First submitted
15 Aug 2021
Last updated
27 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Contaminated Medical or Biological Substances, run by Bnai Zion Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contamination with simulated virus (time frame: 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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