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| Name | Class |
|---|---|
| National Taiwan University Hospital, Yun-Lin Branch | OTHER |
| Hualien Tzu Chi General Hospital | OTHER |
| National Taiwan University Hospital Hsin-Chu Branch | OTHER |
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long CHG Intervention | Experimental | 2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol. |
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| Mid-length CHG Intervention | Experimental | 4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol. |
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| Short CHG Intervention | Experimental | 6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long Intervention | Other | Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 2 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 6-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of catheter-related urinary tract infection | The incidence of CAUTI, according to the updated definition of National Healthcare Safety Network (any Candida species will be excluded as pathogen) | During the entire observation period (12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of catheter-related urinary tract infection (including candiduria) | The incidence of CAUTI, according to the updated definition of National Healthcare Safety Network, but candiduria not excluded as pathogen | During the entire observation period (12 months) |
| Incidence of catheter-related urinary tract infection, by different clinical relevant isolates |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of severe adverse effects related to topical CHG disinfection | The occurrence of severe adverse effects related to topical CHG disinfection | During the entire observation period (12 months) |
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):
Exclusion Criteria (for units):
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| Name | Affiliation | Role |
|---|---|---|
| Yee-Chun Chen, PhD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
Owing to the study design, informed consent is waived by the Research Ethic Committee of National Taiwan University Hospital. Therefore, individual data could not be shared as there is no consent.
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002864 | Chromogranins |
| ID | Term |
|---|---|
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
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| Lotung Poh-Ai Hospital |
| OTHER |
| Min-Sheng General Hospital | OTHER |
Each enrolled units will start with iodine protocol, and then switched to CHG protocol at designated time, followed by CHG plus protocol subsequently. 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.
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|
| Mid-length Intervention | Other | Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 4 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 4-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion. |
|
|
| Short Intervention | Other | Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 6 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 2-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion. |
|
|
The incidence of CAUTI caused by different clinical relevant isolates (Pseudomonas aeruginosa, enterococci, enteric gram-negative bacteria, other pseudomonads, etc.) |
| During the entire observation period (12 months) |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |