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Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device

NCT ID: NCT04605003

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-02-28

Brief Summary

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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

Detailed Description

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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.

Conditions

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Sterility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

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

Study Groups

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Conventional Autoclave

The conventional autoclave is the gold standard of sterilising all medical equipments.

Group Type ACTIVE_COMPARATOR

Novel rig-S

Intervention Type DEVICE

A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed

Conventional Autoclave machine

Intervention Type DEVICE

The gold standard device to clean all medical instruments

Novel rig-S

A novel devise used with the high level disinfectant

Group Type ACTIVE_COMPARATOR

Novel rig-S

Intervention Type DEVICE

A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed

Conventional Autoclave machine

Intervention Type DEVICE

The gold standard device to clean all medical instruments

Interventions

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Novel rig-S

A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed

Intervention Type DEVICE

Conventional Autoclave machine

The gold standard device to clean all medical instruments

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

All rigid endoscopes performed in ORL clinic

Exclusion Criteria

Flexible endoscopes performed in ORL clinic
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universiti Kebangsaan Malaysia Medical Centre

OTHER

Sponsor Role lead

Responsible Party

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Azlina Ab Rani

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salina Husain, MMED

Role: STUDY_DIRECTOR

Universiti Kebangsaan Malaysia Medical Centre

Locations

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Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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Novel rig-S

Identifier Type: -

Identifier Source: org_study_id