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临床试验/NCT05008627
NCT05008627已完成不适用

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

Bnai Zion Medical Center1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
1
主要终点
Contamination with simulated virus

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age limit
  • Staff members who worked in CORONA UNIT

排除标准

  • Staff members who did not work in CORONA UNIT

结局指标

主要结局

Contamination with simulated virus

时间窗: 15 minutes

Quality control observation

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

LUIS GAITINI MD

Associate Clinical Professor of Anesthesiology

Bnai Zion Medical Center

研究点 (1)

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