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

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

Study Overview

• Status: Completed
• Conditions: Sterility
• Intervention / Treatment: Device: Novel rig-S; Device: Conventional Autoclave machine

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • Universiti Kebangsaan Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All rigid endoscopes performed in ORL clinic

Exclusion Criteria:

Flexible endoscopes performed in ORL clinic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Autoclave; The conventional autoclave is the gold standard of sterilising all medical equipments.	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
Active Comparator: Novel rig-S; A novel devise used with the high level disinfectant	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial and Hepatitis B test	Rigid endoscopes are swabbed and tested using a hep-B kit	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acidity level	Acidity level of the high level disinfectant is tested for every 10 cycles of scope	4 hours

Collaborators and Investigators

• Sponsor: Universiti Kebangsaan Malaysia Medical Centre
• Investigators: Study Director: Salina Husain, MMED, Universiti Kebangsaan Malaysia Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 25, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 25, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Novel rig-S

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No