Intended Use: CIDEX® OPA Solution is a high level disinfectant for reprocessing heat sensitive reusable semi-critical medical devices, for which sterilization is. Cidex 14 day use, a % alkaline glutaraldehyde solution, destroys % of Mycobacterium tuberculosis in 45 minutes at 25 degrees Celsius. Cidex OPA®. J Hosp Infect. Jul;54(3) An evaluation of Cidex OPA (% ortho- phthalaldehyde) as an alternative to 2% glutaraldehyde for high-level.
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During this time no submissions or updates will fidex processed. The safety and civex validity of this study is the responsibility of the study sponsor and investigators. Before participating in a study, talk to your health care provider and refer to this information for consumers. A randomised single-blind comparison of the effectiveness of the high-level disinfectants Tristel Fusion chlorine dioxide and Cidex OPA ortho-phthaldehyde for use with flexible cystoscopes Query!
A randomised single-blind comparison of the rate of urinary tract infections in participants undergoing flexible cystoscopy when the flexible cystoscope is disinfected with Tristel Fusion chlorine dioxide compared with Cidex OPA ortho- phthaldehyde Query!
CIDEX OPA World Precision Instruments
Secondary ID  0. Health condition s or problem s studied:. Effectiveness of high level disinfectants for flexible cystoscopes 0 Query! Infection 0 0 Query! Other infectious diseases Query! Tristel Fusion consists of ml chlorine dioxide in aqueous solution. This is diluted in five litres of water. The flexible cystoscope is then immersed in this solution for five minutes and then rinsed thoroughly.
Intervention code  0. Cidex OPA is a solution containing ortho-phthaldehyde which is used in conjunction with a Medivator specialised cleaning machine. The flexible ctstoscope in placed in the Medivator 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 three minute air purge to dry the instrument.
Primary outcome  0. The Primary Endpoint oppa the rate of acquired urinary tract infections as determined by a mid-stream urine test MSU days post intervention in the participants undergoing flexible cystoscopy when the cystoscope is disinfected with Tristel Fusion compared with Cidex OPA. Timepoint  0. A single measurement at days post intervention Query! Secondary outcome fidex 0.
A single measurement at days post intervention which is then compared with baseline Query! Secondary outcome  0. Samples of the washings and brushings are inoculated onto each of Blood Agar and MacConkey Agar and incubated aerobically.
Timepoint  0. Secondary outcome  0. Cost-effectiveness of the 2 disinfectants will be assessed: These costs will include a per-procedure estimate of machine and tray cost, all disposables, irrigation fluids, nursing time and any scope damage caused by the disinfecting agents.
Timepoint  0. Cost effectiveness will be analysed from data from all participants in the trial Query! Secondary outcome  0.
Ease-of-use and odour will be assessed using a 5 point Likert scale Query! Timepoint  0. These will be rated by the nurses using the disinfection equipment on each study day Query!
Participants requiring a cided cystoscope and who provide written informed consent will be eligible to participate. Other inclusion criteria are a negative MSU at baseline, no symptoms of urinary tract infection UTI on the day of investigation, no specific indication for parenteral antibiotic prophylaxis e. Both males and females Query! Can healthy volunteers participate?
Exclusion criteria include the requirement of a biopsy during the procedure. Purpose of the study.
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Randomised controlled trial Query! Procedure for enrolling a subject and allocating the treatment allocation concealment procedures. Participants will be allocated to the next available cystoscopy clinic day.
When all the available spaces for a clinic day are filled, the randomised high level disinfectant i. In this way, investigators allocating participants to a cystoscopy clinic study day do not know which disinfectant will be used on that 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 cystoscopy clinic. It is anticipated that there will be at least 8 clinic study days. The randomisation process will be constructed by the independent statistician to ensure there are equivalent numbers of Tristel Fusion and Cidex OPA study days.
Methods used to generate the sequence in which subjects will be randomised sequence generation. Simple randomisation by using a randomization table created by a computer software i. Blinded masking used Query! It is not possible to blind the people conducting the disinfection since the two products are different in appearance and procedures required.
However the urologists conducting the cystoscopes; the participants reporting the symptoms and the lab staff analysing the mid-stream urine samples will be blinded Query! Type of endpoint s. Date of first participant enrolment.
Date of last participant enrolment. Date of last data collection. Country  0. Bay of Plenty Query! Funding source category  0. Name  0. Tristel Solutions Ltd Query! Address  0.
Secondary sponsor category  0. Ethics committee name  0. Ethics committee address  0.
Research lab equipment for where science takes YOU!
Ethics committee country  0. Date submitted for ethics approval  0. Approval date  0.
Ethics approval number  0. 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 irritant to the respiratory tract and eyes Cidex OPA Directions for Cidec Tristel Solutions Limited 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 xidex file.
Therefore the use of Tristel is expected to pose a very low risk to patients, surgeons and nurses. Contact person for public queries. Contact person for scientific queries. No data has been provided for results reporting. Have study results been published in a peer-reviewed journal? Cides study results been made publicly available in another format?
Results — basic reporting. Results — plain English summary.