None listed
Conditions
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.
Interventions
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
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.
Sponsors
Tristel Solutions Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed