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

N

National University of Malaysia (UKM)

Status

Completed

Conditions

Sterility

Treatments

Device: Conventional Autoclave machine
Device: Novel rig-S

Study type

Interventional

Funder types

Other

Identifiers

NCT04605003
Novel rig-S

Details and patient eligibility

About

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

Full description

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.

Enrollment

500 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

All rigid endoscopes performed in ORL clinic

Exclusion criteria

Flexible endoscopes performed in ORL clinic

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

500 participants in 2 patient groups

Conventional Autoclave
Active Comparator group
Description:
The conventional autoclave is the gold standard of sterilising all medical equipments.
Treatment:
Device: Conventional Autoclave machine
Device: Novel rig-S
Novel rig-S
Active Comparator group
Description:
A novel devise used with the high level disinfectant
Treatment:
Device: Conventional Autoclave machine
Device: Novel rig-S

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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