None listed
Conditions
Brief summary
This study is a randomised double-blind crossover study to determine if the use of an antiseptic wipe prior to self-catheterisation will reduce urinary tract infections in the community. The study will run for 12 months, where participants in the community will undergo 6 months using wipe A and 6 months using wipe B (wipes solution will be blinded to the participants). Participants will report any urinary tract infections throughout the study. At the conclusion of the study the incidence of urinary tract infections in the control and intervention periods will be compared and assessed to determine whether an antiseptic wipes helps reduce the risk of a UTI.
Interventions
A randomized, double-blind, cross-over placebo-controlled study will be undertaken over 12 months. Participants will enter one arm of the study for 6 months before crossing over for another 6 months.
In the intervention period, wipes provided to participants will contain 0.1% chlorhexidine solution - containing no alcohol, soap or equivalent. Participants will use a wipe to clean the meatal area prior to self-catheterisation twice daily (first and fourth catheterisation of the day), with contr
A randomized, double-blind, cross-over placebo-controlled study will be undertaken over 12 months. Participants will enter one arm of the study for 6 months before crossing over for another 6 months. In the intervention period, wipes provided to participants will contain 0.1% chlorhexidine solution - containing no alcohol, soap or equivalent. Participants will use a wipe to clean the meatal area prior to self-catheterisation twice daily (first and fourth catheterisation of the day), with control wipes for any other catheterisations on that day. Chlorhexidine has some residual bactericidal effect, hence it is important to determine whether once a day or use prior to catheterisation is needed. Chlorhexidine has been used safely in clinical trials in the past, and is commonly used at higher concentrations than proposed in this study. There will be a washout period between transitioning between the phases between 1-3 weeks. This is purely pragmatic, to allow time for the intervention to be changed. In the washout period patients will use their regular wipes. We do not anticipate any residual or carry-over effect between the two arms of the study. Participants will be posted the wipes from the research team to their home address. Products will be supplied, such that usage can be monitored and that the correct wipes are being used. Instructions on how to use the wipe will be provided to participants and included in the product supply. During the washout phase, participants will be asked to tell researchers how many wipes are remaining, and then to put all provided wipes in the bin. They will then be supplied with a new set of wipes to be used. Wipe packaging and wipe appearance will be the same, allowing participants to be blinded to the control and intervention wipes.
Sponsors
Avondale University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 18 years and older. • Undertake intermittent catheterisation, either themselves (self-catheterisation) or by a caregiver or healthcare worker • Are likely to be undertaking self-catheterisation for >12 months.
Exclusion criteria
• Unable to provide informed consent due to cognitive impairment. • Hospital in-patient. • Receiving palliative care. • Less than 18 years old. • Has a medical condition contraindicating them from participation, including a known allergy to any ingredient in the supplied product • Fails sensitivity testing for chlorhexidine.
Outcome results
None listed