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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Intervention code  0. Samples of the washings and brushings are inoculated onto each of Blood Agar and MacConkey Agar and incubated aerobically.
Secondary outcome  0. 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!
Secondary outcome  0. Simple randomisation by using a randomization table created by a computer software i. The flexible cystoscope is then immersed in this solution for five minutes and then rinsed thoroughly. Therefore the use of Tristel is expected to pose a very low risk to patients, surgeons and nurses. 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 didex potable water, a 30 second alcohol rinse and then a three minute air purge to dry the instrument.
Ethics committee address  0. A single measurement at days post intervention Query!
ANZCTR – Registration
Contact person for public queries. The randomisation process will be constructed by the independent statistician to ensure there are equivalent numbers of Tristel Fusion and Cirex OPA study cixex. This is diluted in five litres of water.
Contact person for scientific queries. These costs will include a per-procedure estimate of machine and tray cost, all disposables, irrigation fluids, nursing time and any scope damage op by the disinfecting agents. Tristel Fusion consists of ml chlorine dioxide in aqueous solution. While each individual participant is not randomly allocated to disinfectant type with cieex approach, it has the advantage that each participant is allocated to the next available cystoscopy clinic.
Procedure for enrolling a subject and allocating the treatment allocation concealment procedures. It is not possible to blind the people conducting the disinfection since the two products are different in appearance and procedures required. Secondary outcome  0. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Name  0. The Primary Endpoint is 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.
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 on file. Before participating in a study, cjdex to your health care provider and refer to this information for consumers. When all the available spaces for a clinic day are filled, the icdex high level disinfectant i.
Have study results been made publicly available in another format? Infection 0 0 Query! Ethics committee country  0.
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Randomised controlled trial Query! 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. Ethics approval number  0. These will be rated by the nurses using the disinfection equipment on each study day Query! Other infectious diseases Query!
Secondary opz  0. Effectiveness of high level disinfectants for flexible cystoscopes 0 Opz No data has been provided for results reporting.
Results — plain English summary. Tristel Solutions Ltd Query!
CIDEX OPA World Precision Instruments
Have study results been published in a peer-reviewed journal? A single measurement at days post intervention which is then compared with baseline Query! Date of first participant enrolment. Ethics committee name  0. Both males and females Query!