National Taiwan University Hospital
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: 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. CHG protocol: instead of povidone-iodine solution, use 2% aqueous CHG solution as the primary disinfectant during Foley solution. CHG plus protocol: additional to 2% CHG solution, added 0.5% CHG impregnated gel as the lubrication during Foley insertion.
Urinary Tract Infections
Long Intervention
Mid-length Intervention
Short Intervention
Not Applicable
This is a open-labelled, cluster-randomized, step-wedged clinical trial aimed to observe the incidence if CAUTI during the designated study period (12 months for all participated units). All included units will start with the iodine protocol, which is the standard practice in the hospital, and then switched to CHG protocol than CHG plus protocol according to the results of randomization. Each unit will be randomized in to three different groups (A, B, and C): Group A) 2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol. Group B) 4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol. Group C) 6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol. All unit will be monitored and compared for the occurrence of CAUTI, which is defined in accordance to the definition from the National Healthcare Safety Network (USCDC).}}
| Study Type : | Interventional |
| Estimated Enrollment : | 15000 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Prevention |
| Official Title : | A Multi-center, Stepped-wedge, Cluster-randomized Control Trial to Evaluation the Effectiveness of Chlorhexidine to Prevent Catheter-associated Urinary Tract Infection |
| Actual Study Start Date : | March 1, 2023 |
| Estimated Primary Completion Date : | March 31, 2024 |
| Estimated Study Completion Date : | March 31, 2024 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Long CHG Intervention 2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol. |
Other: Long Intervention |
|
Experimental: Mid-length CHG Intervention 4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol. |
Other: Mid-length Intervention |
|
Experimental: Short CHG Intervention 6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol. |
Other: Short Intervention |
| Ages Eligible for Study: | |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100