Chlorhexidine to Prevent Catheter-related Urinary Tract Infection
Taiwan30,994 participantsStarted 2023-03-01
Plain-language summary
The study is to investigate whether chlorhexidine (CHG)-based antiseptics is more effective to prevent catheter-related urinary tract infection (CAUTI) among inhospital patients who required Foley catheter insertion. This is a cluster-randomised, step-wedged clinical trial, in which every participated unit will used three different Foley catheter insertion protocols during the study period:
1. Iodine protocol: using 10% povidone-iodine as the primary antiseptic during Foley insertion. This is the routine practice before this study in the participated hospital, as well as many Taiwanese hospitals.
2. CHG protocol: instead of povidone-iodine solution, use 2% aqueous CHG solution as the primary disinfectant during Foley solution.
3. CHG plus protocol: additional to 2% CHG solution, added 0.5% CHG impregnated gel as the lubrication during Foley insertion.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
This is a cluster-randomized clinical trial. The enrollment is for healthcare units (wards, ICUs) in the participated hospitals rather than individuals. Patients who were admitted in the included unit with be enrolled in our study automatically.
Inclusion Criteria (for units):
* Adult acute care wards or intensive care units, which primarily care for adult patients aged above 18 years.
* Currently not using chlorhexidine as disinfectants for Foley catheter insertion or routine care.
* Had patients who required Foley catheter insertion during the last 12 months prior to inclusion.
* Willing to implant measures to improve the rate of CAUTI, and to participate and follow the study protocol in our study.
Exclusion Criteria (for units):
* Units currently using chlorhexidine as disinfectants for Foley catheter insertion or routine care.
* Wards or intensive care units with patients aged below 18 years of age in their routine practice.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of catheter-related urinary tract infection
Timeframe: During the entire observation period (12 months)