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Effect of chlorhexidine 0.1% wipes on catheter associated urinary tract infections: a double-blind randomised control trial

Effect of chlorhexidine 0.1% wipes on catheter associated urinary tract infections in adult inpatients: a double-blind randomised control trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000278437
Acronym
CATION 2.0
Enrollment
1200
Registered
2025-04-11
Start date
2025-08-04
Completion date
2026-06-23
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

One of the most common healthcare associated infection are catheter associated urinary tract infections. Emerging evidence suggesting the benefits of cleaning the meatal area with an antiseptic prior to urinary catheterisation, may help reduce the risk of these infections. We aim to evaluate the efficacy of cleaning the urethral meatal area with antiseptic prior to urinary catheter insertion for the prevention of catheter-associated urinary tract infections. We hypothesise that the use of chlorhexidine 0.1%, compared to saline for cleaning the urethral area prior to catheterisation will reduce the risk of infection. We will compare the use of saline against chlorhexidine (0.1%) in a double blind randomised control trial.

Interventions

The intervention is the use of a sterile wipe, containing 0.1% chlorhexidine solution, for meatal cleaning prior to urinary catheter insertion. The intervention will be delivered by a specific staff member or members at the hospital. A single wipe will be used once, for the cleaning process, which should take approximately 15 seconds. The intervention will be administrated by a registered nurse or medical doctor. Adherence will be monitored through audits of medical records.

Sponsors

Avondale University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- inpatients in the enrolled hospital - 18 years of age and over - persons receiving an indwelling urinary catheter as determined as part of their usual medical care.

Exclusion criteria

- under 18 years of age - an allergy, contraindication or other medical reason preventing the use of the intervention for cleaning the urethral meatal area - those who require in-and-out or suprapubic catheterisation - those with symptoms and signs suggestive of UTI and patients already undergoing treatment for UTI.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026