None listed
Conditions
Brief summary
Approximately 1% of all patients (around 95,000 per year), who go to hospital acquire a urinary tract infection (UTI). It has been suggested that up to 80% of hospital associated UTS’s are caused by the use of a urinary catheter. Insertion of the catheter is an important part of reducing the risk of infection. There is wide variation in practice relating to cleaning the urethral meatus area before catheter insertion. This study intends to ascertain if cleaning the urethral meatus with saline 0.9% (Control) or an antiseptic chlorhexidine 0.1% (Intervention) reduces the instances of infection. The benefits relating to the outcomes of this study are to reduce the risk of infection and therefore it’s associated cost savings. The research hypotheses 1. When undertaking meatal cleaning prior to indwelling urinary catheter insertion, there is no difference between the use of normal saline (0.9%) and chlorhexidine (0.1%) solution on the incidence of catheter-associated urinary tract infections (CAUTIs). 2. The use of chlorhexidine (0.1%) solution for meatal cleaning prior to urinary catheter insertion is not a cost-effective intervention to reduce CAUTI. Study design A multi-site stepped wedge randomised controlled trial will be undertaken in three large tertiary hospitals (approximately 2640 participants) over a 32-week period, with a random sequential allocation of the intervention to three hospitals. The study design enables each hospital to act as its own control, which removes the potential for some confounders such as variations in hospital size and case mix and differences between public and private hospitals. Staggered commencement and duration of the intervention, either 2,4 or 6 months, supports feasibility while maintaining the rigour of the study. The number of catheter associated UTIs will be analysed using Poisson regression, with the number of cases as the dependent variable and number of patient catheter days as the denominator. This denominator will help control for changes in catheter use during the study period. The key independent variable will be the intervention.
Interventions
The intervention will consist of clinical staff using a 0.1% chlorhexidine solution for meatal cleaning i.e. the urethral insertion site area will be swabbed using chlohexidine immediaely prior to urinary catheter insertion. Fidelity of the swabbing process will not be assessed. due to patient privacy issues.
Sponsors
Avondale College
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The hospital must meet the following inclusion criteria: 1. Has an intensive care unit. 2. Is classified by the Australian Institute of Health and Welfare as a principal referral hospital OR a public acute group A hospital (with more than 400 beds), OR in the case of a private hospital has 400 inpatient beds OR has more than 30,000 patient admissions per year.
Exclusion criteria
The study will be a hospital wide study, but with the following exclusion criteria: - Patients that do not require a catheter. - Individual areas within a hospital that are not considered appropriate for the intervention - Neonatal intensive care departments - Any patient less than 2 years old - Patients with indwelling urinary catheters inserted in theatre. - Patients with an allergy, contraindication or other medical reason preventing the use of the intervention for cleaning the urethral meatal area will be excluded. Patients who require in-and-out or suprapubic catheterisation will also be excluded as well as those with symptoms and signs suggestive of UTI and patients already undergoing treatment for UTI. Hospitals could be excluded from the study if within the study time frame they are; undertaking a project that may influence the outcomes measured in this study; opening, closing or relocating
Outcome results
None listed