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| Name | Class |
|---|---|
| Fondazione Toscana Gabriele Monasterio | OTHER |
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The study will assess the utility of 4% chlorhexidine gluconate (CHG) daily bathing to reduce hospital acquired infections in patients admitted to intensive care units. One group will be daily bathed with 4% CHG and the other group with standard soap.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | daily bathing with 4% chlorhexidine gluconate soap-like solution followed by water rinsing |
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| Control Arm | Active Comparator | daily bathing with standard soap |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4% chlorhexidine gluconate soap-like solution | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| hospital acquired infections incidence | cumulative incidence of bloodstream infections (BSI), central line-associates BSI (CLABSI), urinary tract infections (UTI), catheter-associated UTI (CAUTI) and ventilator-associated pneumonias (VAP) | infections occured 48 hours after admission to ICU/PC-ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-associated pnemonias (VAP) incidence | VAP incidence | infections occured 48 hours after admission to ICU/PC-ICU |
| Bloodstream infections (BSI) incidence | BSI incidence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| franco baldelli, Professor | Infectious Diseases Clinical, University Hospital of Perugia, Perugia, Italy | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30267930 | Derived | Pallotto C, Fiorio M, De Angelis V, Ripoli A, Franciosini E, Quondam Girolamo L, Volpi F, Iorio P, Francisci D, Tascini C, Baldelli F. Daily bathing with 4% chlorhexidine gluconate in intensive care settings: a randomized controlled trial. Clin Microbiol Infect. 2019 Jun;25(6):705-710. doi: 10.1016/j.cmi.2018.09.012. Epub 2018 Sep 26. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2015 | Aug 13, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| standard soap | Other |
|
|
| infections occured 48 hours after admission to ICU/PC-ICU |
| central-line associated BSI (CLABSI) incidence | CLABSI incidence | infections occured 48 hours after admission to ICU/PC-ICU |
| urinary tract infections (UTI) incidence | UTI incidence | infections occured 48 hours after admission to ICU/PC-ICU |
| catheter associated UTI (CAUTI) incidence | CAUTI incidence | infections occured 48 hours after admission to ICU/PC-ICU |
| 4% CHG daily bathing safety | overall mortality in the treatment and control arm | at discharge, approximately up to 10 days |
| 4% CHG daily bathing-related adverse events | 4% CHG daily bathing-related adverse events in the treatment arm compared to standard soap-related adverse events | at discharge, approximately up to 10 days |
| time till infection | time between admission to ICU/PC-ICU and infection occurrence | at discharge, approximately up to 10 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |