Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000483853
Ethics application status
Approved
Date submitted
26/04/2012
Date registered
2/05/2012
Date last updated
8/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison study of cost-effectiveness, patient satisfaction and microbiological effectiveness of the high-level disinfectants Tristel Wipes, Cidex OPA and PeraSafe
Scientific title
A randomised single-blind comparison of cost-effectiveness, patient satisfaction, and microbiological effectiveness of the high-level disinfectants Tristel Wipes (chlorine dioxide), Cidex OPA (ortho-phthaldehyde) and PeraSafe (peracetic acid/peracetyl ions) in participants requiring a flexible nasoendoscope
Secondary ID [1] 280366 0
TSL-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effectiveness of high level disinfectants on flexible nasoendoscopes 286339 0
Condition category
Condition code
Infection 286584 286584 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Tristel Wipes System provides high level disinfection for non-lumened medical instruments. The first step is the Pre-clean Wipe which is impregnated with a low-foaming surfactant system combined with triple enzymes, the second step is the Sporicidal Wipe and Activator Foam which is sporicidal, mycobactericidal, bactericidal, virucidal and fungicidal and the third step is the Rinse Wipe which is impregnated with de-ionised water and a low-level of antioxidant which has been gamma irradiated to make sterile. The three step process takes under two minutes and is carried out immediately post nasoendoscopy.
Intervention code [1] 284734 0
Prevention
Comparator / control treatment
Comparator Arm 1 - Cipex OPA is a solution containing ortho-phthaldehyde which is used in conjunction with an Automated Endoscopic Reprocessor (AER). The flexible nasoendoscope is placed in the AER and the cleaning cycle initiated. The cycle consists of a 10 minute soaking and soak rinse phase in Cidex OPA, a rinse 1 phase for 7 minutes in potable water, a rinse 2 phase for 6 minutes in potable water, a 30 second alcohol rinse and then a 3 minute air purge to dry the instrument. The process is carried out immediately post nasoendoscopy.
Comparator Arm 2 - PeraSafe is a powder system which when dissolved in water yields peracetyl ions, peracetic acid and hydrogen peroxide giving an aqueous solution and functions by oxidising proteins. Perasafe powder is added directly to a container of lukewarm water until it has dissolved and then transferred to a cyclinder. The working portion of the nasoendoscope is immersed in the solution of PeraSafe contained within a cylinder for a minimum of 10 minutes and is carried out immediately post nasoendoscopy.
Control group
Active

Outcomes
Primary outcome [1] 287005 0
The patients perception of the procedure immediately following their flexible nasoendoscopy. This is measured by a Visual Analogue Scale (VAS) rating scale from 0-10cm.
Timepoint [1] 287005 0
A single measurement immediately post procedure.
Primary outcome [2] 287006 0
Microbiology Endpoints
-Equipment samples collected following disinfection immediately prior to use of the scope by swabbing the tip and shoulder of the nasoendoscope.
-Culture of samples collected from the AER inner lid and exit port after the first and last disinfection on each study day and also of the inside of the PeraSafe cylinder.
Timepoint [2] 287006 0
Post disinfection.
Primary outcome [3] 287007 0
Cost effectiveness of the 3 disinfectants used
-The total per-patient cost of high-level disinfection with the Tristel Wipes, Cidex OPA and PeraSafe systems will be calculated using data collected from the participants undergoing nasoendoscopy. These costs will include a per-procedure estimate of the AER and cylinder, all disposables, irrigation fluids, nursing time and scope damage caused by the disinfectants.
-Timing of the 3 processess and measurement of participant through-put; time needed for the cleaning process as an indicator of relative efficiency.
Timepoint [3] 287007 0
Cost effectiveness will be analysed from data from all participants in the trial.
Secondary outcome [1] 297184 0
Ease-of-use and odour will be assessed using a 5 point Likert scale.
Timepoint [1] 297184 0
These will be rated by the nurses using the disinfection equipment on each study day.
Secondary outcome [2] 297185 0
Participant, surgeon and nursing staff safety
-all participant adverse events will be recorded regardless of whether these are likely to be related to the disinfectant. Any adverse event is unlikely following nasoendoscopy other than mild irritation or rhinorrhea.
-incidence and severity of eye irritation and conjunctivitis or other reactions will be reported by the surgeon using the nasoendoscope on the study day
Timepoint [2] 297185 0
-participant AEs recorded 3-7 days post nasoendoscope
-surgeon reaction up to 3 days post nasoendoscope

Eligibility
Key inclusion criteria
Participants requiring a flexible nasoendoscope and who provide written informed consent will be eligible to participate. Other inclusion criteria are aged at least 18 years on the day of consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known to be allergic to topical cophenylcaine spray or any of the disinfectants to be used in the study, have taken antibiotics in last 7 days, have had nasal surgery in last 6 months and are known to be Hepatitis B and/or HIV positive.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be allocated to the next available nasoendoscopy clinic. When all the available spaces for a clinic are filled, the randomised high level disinfectant (i.e. Tristel Wipes, PeraSafe or Cidex OPA) for that day will be determined by the study statistician and relevant staff notified. In this way, investigators allocating participants to a clinic day do not know which disinfectant will be used on the day. While each individual participant is not randomly allocated to disinfectant type with this approach, it has the advantage that each participant is allocated to the next available clinic. It is anticipated that there will be at least 30 clinic study days. The randomisation process will be undertaken by the independent statistician to ensure there are equivalent numbers of Tristel Wipes, PeraSafe and Cidex OPA study days and approximately equal numbers of participants in each disinfectant group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
It is not possible to blind the people conducting the disinfection since the three products are different in appearance and procedures required. However the ENT surgeons and the participants will be blinded.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
195
Accrual to date
Final
Recruitment outside Australia
Country [1] 4275 0
New Zealand
State/province [1] 4275 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 285169 0
Commercial sector/Industry
Name [1] 285169 0
Tristel Solutions Ltd
Country [1] 285169 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Tristel Solutions Ltd
Address
Lynx Business Park
Fordham Road
Snailwell
Cambridgeshire CB8 7NY
Country
United Kingdom
Secondary sponsor category [1] 284036 0
None
Name [1] 284036 0
Address [1] 284036 0
Country [1] 284036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287178 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 287178 0
PO Box 1031
Hamilton 3240
Ethics committee country [1] 287178 0
New Zealand
Date submitted for ethics approval [1] 287178 0
Approval date [1] 287178 0
21/04/2010
Ethics approval number [1] 287178 0
NTY/10/01/001

Summary
Brief summary
There are several methods and agents whihc can be used to provide high-level disinfection of 'semi-critical' instruments such as flexible nasoendoscopes, however non-corrosive methods are required because of the composition of the instrument.
Cidex OPA (ortho-Phthalaldehyde;1,2 - benzenedicarboxaldehyde) has been widely used for high-level disinfection but may elicit an allergic reaction in workers if protective equipment is not used and the vapours produced may be an irrtant to the respiratory tract and eyes (Cidex OPA Directions for Use; 2004). Perasafe solution is at pH 8.0 at which peracetic acid and peracetyl ions exist at a 50:50 mixture to minimize corresiveness and maximise efficacy against acid resistant bacteria (PeraSafe product information-DuPont).
Tristel Solutions Ltd (UK) produces a range of high-level disinfectant products which use chlorine dioxide chemistry and the products have also been used as a disinfectant for a wide variety of instruments and surfaces without safety issues (Tristel data file). Therefore the use of Tristel Wipes is expected to pose a very low risk to patients, surgeons and nurses. If Tristel Wipes are shown to be at least ast effective as Cidex OPA and PeraSafe in terms of post-intervention complications for patients, less in-use problems for the surgeons and nurses, then it may be a preferable product to use for high-level disinfection of nasoendoscopes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34096 0
Address 34096 0
Country 34096 0
Phone 34096 0
Fax 34096 0
Email 34096 0
Contact person for public queries
Name 17343 0
Sonia Moynan
Address 17343 0
Clinical Trials Unit, Bay of Plenty Clinical School
Tauranga Hospital
Cameron Road
Private Bag 12024
Tauranga 3143
Country 17343 0
New Zealand
Phone 17343 0
+64 7 579 8797
Fax 17343 0
+64 7 578 0895
Email 17343 0
Sonia.Moynan@bopdhb.govt.nz
Contact person for scientific queries
Name 8271 0
Brandon Hitchcock
Address 8271 0
Tauranga Hospital
Cameron Road
Private Bag 12024
Tauranga 3143
Country 8271 0
New Zealand
Phone 8271 0
+64 7 579 8797
Fax 8271 0
+64 7 578 0895
Email 8271 0
Brandon.Hitchcock@bopdhb.govt.nz

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No Supporting Document Provided



Results publications and other study-related documents

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