Investigating if the use of an antiseptic wipe can prevent catheter-associated infections in the community.

INTERVENTION: 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 CONDITION: Catheter‐associated infections;Urinary tract infection; ; Catheter‐associated infections ; Urinary tract infection Infection ‐ Studies of infection and infectious agents Public Health ‐ Health service research PRIMARY OUTCOME: To evaluate the efficacy in reducing the incidence of UTI of a 0.1% chlorhexidine solution, compared with normal practice for meatal cleaning before urinary catheter insertion.; ; A survey with screening questions will be used to identify the potential of a UTI. A follow‐up phone call with participants will occur monthly when needed, based on the self reporting of symptoms in the survey.[This outcome will be monitored monthly, through monthly follow up of participants throughout the study. This will occur until the end of the study i.e. 12 months.; ] 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. SECONDARY OUTCOME: Time to UTI (in days).[This outcome will be monitored monthly, through monthly follow up of participants throughout the study via a survey. The survey has been designed for this study. The outcome is self‐reported. If the survey indicates a self reported UTI, a follow up phone call will occur. This will occur until the end of the study i.e. 12 months.] To estimate the cost‐effectiveness of using antiseptics for meatal cleaning. ; ; Cost‐effectiveness will be assessed from data obtained from the study and existing literature. Data obtained from the study will include the additional cost of the product used (chlorhexidine), duration of infection; details on any consultation/s with general practitioner; treatment costs, including antibiotic therapy (type, dose, duration) and detail on any admission to hospital (or ED attendance) relating to the UTI. These details would include presentation reason, time in hospital, and recall of any diagnostic tests. These data will be sourced from a follow‐up phone call with participants, monthly when needed, based on the self reporting of symptoms in the routine monthly survey. ; ; Data on quality of life of participants with a UTI will also be used in the cost‐effectiveness evaluation. These data will be obtained from the study, in addressing another secondary outcome (described below). ; [This outcome will be evaluated at the end of the trial i.e. 12 months. ] To explore the effect of UTIs on the quality of life of participants who undertake intermittent catheterisation, either themselves (self‐catheterisation) or by a caregiver or healthcare worker.[The interview will be conducted when (if) a person has a UTI. ; ; Assessment of the impact of UTIs on quality of life will use EQ‐5D, a questionnaire measuring 5 dimensions of health. This will be undertaken by a member of the research team and would be expected to take less than 10 minutes. This will occur when a participant has a UTI over the 12 month study period. Follow up will cease once at 12 months.] To explore the personal experience of participants who undertake intermittent catheterisation, either themselves (self‐catheterisation) or by a caregiver or healthcare worker. ; Semi structured audio recorded interviews by a member of the research team will be used to evaluate this outcome. Interviews are expected to take 30 minutes.[The interview will be conducted at the completion of the trial i.e. 12 months]