Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device
Primary Purpose
Sterility
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Novel rig-S
Conventional Autoclave machine
Sponsored by
About this trial
This is an interventional other trial for Sterility
Eligibility Criteria
Inclusion Criteria:
All rigid endoscopes performed in ORL clinic
Exclusion Criteria:
Flexible endoscopes performed in ORL clinic
Sites / Locations
- Universiti Kebangsaan Malaysia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional Autoclave
Novel rig-S
Arm Description
The conventional autoclave is the gold standard of sterilising all medical equipments.
A novel devise used with the high level disinfectant
Outcomes
Primary Outcome Measures
Microbial and Hepatitis B test
Rigid endoscopes are swabbed and tested using a hep-B kit
Secondary Outcome Measures
Acidity level
Acidity level of the high level disinfectant is tested for every 10 cycles of scope
Full Information
NCT ID
NCT04605003
First Posted
October 16, 2020
Last Updated
October 25, 2020
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT04605003
Brief Title
Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device
Official Title
Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Kebangsaan Malaysia Medical Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sterility
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The swabbing of the endoscopes are performed by a research assistant, and the end result is evaluated by the primary investigator
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Autoclave
Arm Type
Active Comparator
Arm Description
The conventional autoclave is the gold standard of sterilising all medical equipments.
Arm Title
Novel rig-S
Arm Type
Active Comparator
Arm Description
A novel devise used with the high level disinfectant
Intervention Type
Device
Intervention Name(s)
Novel rig-S
Intervention Description
A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed
Intervention Type
Device
Intervention Name(s)
Conventional Autoclave machine
Intervention Description
The gold standard device to clean all medical instruments
Primary Outcome Measure Information:
Title
Microbial and Hepatitis B test
Description
Rigid endoscopes are swabbed and tested using a hep-B kit
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Acidity level
Description
Acidity level of the high level disinfectant is tested for every 10 cycles of scope
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All rigid endoscopes performed in ORL clinic
Exclusion Criteria:
Flexible endoscopes performed in ORL clinic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salina Husain, MMED
Organizational Affiliation
Universiti Kebangsaan Malaysia Medical Centre
Official's Role
Study Director
Facility Information:
Facility Name
Universiti Kebangsaan Malaysia
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device
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