- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Kuala Lumpur
-
Cheras, Kuala Lumpur, Malaysia, 56000
- Universiti Kebangsaan Malaysia
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
All rigid endoscopes performed in ORL clinic
Exclusion Criteria:
Flexible endoscopes performed in ORL clinic
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Conventional Autoclave
The conventional autoclave is the gold standard of sterilising all medical equipments.
|
A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed
The gold standard device to clean all medical instruments
|
Aktiv komparator: Novel rig-S
A novel devise used with the high level disinfectant
|
A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed
The gold standard device to clean all medical instruments
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Microbial and Hepatitis B test
Tidsramme: 3 days
|
Rigid endoscopes are swabbed and tested using a hep-B kit
|
3 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Acidity level
Tidsramme: 4 hours
|
Acidity level of the high level disinfectant is tested for every 10 cycles of scope
|
4 hours
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Salina Husain, MMED, Universiti Kebangsaan Malaysia Medical Centre
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Novel rig-S
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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