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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Secondary outcome opz 0. Date of first participant enrolment. Procedure for enrolling a subject and allocating the treatment allocation concealment procedures.
Ethics committee name  0. These will be rated by the nurses using the disinfection equipment on each study day Query! Timepoint  0. Secondary ID  0. Ethics committee country  0. Secondary outcome  0. 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 cirex for a wide variety of instruments and surfaces cixex safety issues Tristel data on file.
Ease-of-use and odour will be assessed using a 5 point Likert scale Query! The randomisation process will be constructed by the independent statistician to ensure there are equivalent numbers of Tristel Fusion and Cidex OPA study days. Purpose of the study. Methods used to generate the sequence in which subjects will be randomised sequence generation.
Secondary sponsor category  0.
Other infectious diseases Query! 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!
J&J / ASP Cidex OPA Solution High Level Disinfectant -GA – Buy Online From Chicago Medical Supply
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. Timepoint  0. Approval date  0. Bay of Plenty Query! Country  0. Timepoint  0. A single measurement at days post intervention Query! It is anticipated that there will be at least 8 clinic study days.
Tristel Solutions Ltd Query! This is diluted in five litres of water. Simple randomisation by using a randomization table created by a computer software i. Intervention code  0.
Name  0. Date of last participant enrolment. Type of endpoint s.
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Address cideex 0. Contact person for public queries. The flexible cystoscope is then immersed in this solution for five minutes and then rinsed thoroughly.
Timepoint  0. Tristel Fusion consists of ml chlorine dioxide in aqueous solution.
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It is not possible to blind the people conducting the disinfection since the two products are different in appearance and procedures required. 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 Use; Results — plain English summary.
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. 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!
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Secondary outcome  0. Contact person for scientific queries. The safety and scientific validity of this study is the o;a of the study sponsor and investigators.