4% Chlorhexidine Gluconate Daily Bathing for Prevention of Hospital-acquired Infections in Intensive Care Settings

Study Overview
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Brief Summary
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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.

Official Title
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Study on the Effect of the Universal Decontamination With Daily Bathing With 4% Chlorhexidine Gluconate on the Incidence of Hospital Acquired Infections in Intensive Care Units

Conditions
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Hospital Infection

Intervention / Treatment
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* Drug: 4% chlorhexidine gluconate soap-like solution
* Other: standard soap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: admission to the intensive care unit (ICU) or to the post-operative cardiosurgical ICU (PC-ICU) ICU/PC-ICU stay for at least 1 night Exclusion Criteria: known allergy to chlorhexidine burns, toxic epidermal necrolysis or Stevens-Johnson syndrome as admission diagnosis pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>daily bathing with 4% chlorhexidine gluconate soap-like solution followed by water rinsing | Drug: 4% chlorhexidine gluconate soap-like solution<br>* humidify the whole body surface with the exception of the face using water-impregnated washcloths use 4% CHG-impregnated washcloths to bath the whole body surface with the exception of the face; use at least 30 ml of 4% CHG wait for at least 30 seconds rinse using water-impregnated washcloths<br>|
| Active Comparator: Control Arm<br>daily bathing with standard soap | Other: standard soap<br>* humidify the whole body surface with the exception of the face using water-impregnated washcloths use standard soap-impregnated washcloths to bath the whole body surface with the exception of the face wait for at least 30 seconds rinse using water-impregnated washcloths<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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4% chlorhexidine gluconate, infection control