Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05712434
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2023-01-25
Brief Title:
Chlorhexidine to Prevent Catheter-related Urinary Tract Infection
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Multi-center Stepped-wedge Cluster-randomized Control Trial to Evaluation the Effectiveness of Chlorhexidine to Prevent Catheter-associated Urinary Tract Infection
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 05 CHG impregnated gel as the lubrication during Foley insertion
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 05 CHG impregnated gel as the lubrication during Foley insertion
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None