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临床试验/NCT04605003
NCT04605003已完成不适用

Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device: A Randomized Controlled Trial

Universiti Kebangsaan Malaysia Medical Centre2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
2
主要终点
Microbial and Hepatitis B test

研究概览

简要总结

This study compares the sterility of rigid nasoendoscopies after being sterilized with a conventional autoclave machine and a novel rig-S device that uses standard high level disinfectant

详细描述

There is a standard operating procedure in rigid endoscopy cleaning, and it is performed after each clinical examination. The conventional autoclave is no longer used in the setting of an otorhinolaryngology (ORL) clinic as it is cumbersome and takes a lot of time, and also only cleans one endoscope at a time. There is no standardisation or device that has been reported, and cross contamination has been reported previously. The overturn of patients in the ORL clinic is high, and most practitioners chooses high level disinfectant as a method of sterilising the endoscopes. However, there is no proper device to place these disinfectants in, and results in many cases of broken scopes and cross contamination.

This study compares the sterility of the rigid endoscopes after being sterilised by the high level disinfectant that is placed in a novel rig-S device with the gold standard conventional autoclave.

The investigators selected all the rigid endoscopes performed in our ORL clinic and randomised them before subjecting them for a swab test for bacterial and fungal, and also used a test kit to test the presence of Hepatitis B.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

盲法说明

The swabbing of the endoscopes are performed by a research assistant, and the end result is evaluated by the primary investigator

入排标准

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

入选标准

  • All rigid endoscopes performed in ORL clinic

排除标准

  • Flexible endoscopes performed in ORL clinic

结局指标

主要结局

Microbial and Hepatitis B test

时间窗: 3 days

Rigid endoscopes are swabbed and tested using a hep-B kit

次要结局

  • Acidity level(4 hours)

研究者

发起方
Universiti Kebangsaan Malaysia Medical Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Azlina Ab Rani

Principal investigator

Universiti Kebangsaan Malaysia Medical Centre

研究点 (2)

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