NCT04605003

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Universiti Kebangsaan Malaysia Medical Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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

• Sterility

Interventions

Type	Name	Description
DEVICE	Novel rig-S	A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed
DEVICE	Conventional Autoclave machine	The gold standard device to clean all medical instruments

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2020-10-27
• Last updated: 2020-10-27

Locations

1 site across 1 country: Malaysia