Chlorhexidine Bathing to Prevent Hospital-acquired Infections: the CLEANS Study

Study Overview
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Brief Summary
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Hospital-acquired infections (HAI) have been shown to increase length of hospital stay and mortality. Infections acquired during a hospital stay have been shown to be preventable. The skin of patients is considered a major reservoir for pathogens associated with hospital-acquired infections, and has been suggested as a potential target for interventions to reduce bacterial burden and subsequent risk of infection. The use of daily Chlorhexidine (CHG) bathing in intensive care patients has been advocated to reduce many of the infections in critically ill patients. However, the effectiveness of CHG bathing to reduce ICU infections has varied considerably among published trials, making the effectiveness of CHG bathing in ICU patients uncertain.

Official Title
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Effect of Chlorhexidine Bathing on Prevention of Hospital-Acquired Infections in Patients After Surgery in ICU: A Prospective, Single-Center, Single-Blind, Randomized Controlled Trial

Conditions
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Chlorhexidine, Hospital-Acquired Infection, Surgery, Intensive Care Unit

Intervention / Treatment
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* Other: 2% Chlorhexidine bathing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults (≥ 18-years old) anticipated SICU stay for 48 hours or more APACHE II >15 Exclusion Criteria: Braden Scale for Predicting Pressure Sore Risk score more than 9 (highest risk) pregnancy skin irritation chlorhexidine allergy SICU stay of more than 48 hours prior to screening

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>Patients were daily bathed with soap and water only. | |
| Experimental: Intervention arm<br>Patients were daily bathed with soap and water and then receive 2% Chlorhexidine bathing (Petel Skin care wipes, Likang LtD, shanghai, China). | Other: 2% Chlorhexidine bathing<br>* Eight chlorhexidine-impregnated cloths are used in sequential order to wipe the body surfaces from neck to toe to avoid exposure of chlorhexidine to the mucous membranes of the eyes, ears and mouth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hospital-acquired infections | Including bloodstream infections (BSI), central line-associated BSI (CLABSI), ventilator-associated pneumonia (VAP) and catheter-associated urinary tract infection (CAUTI). | throughout study completion, an average of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidrug-resistant bacterial colonization free time | Time that the swab samples collected from axilla and groin were persistently negative for target MDR throughout ICU admission. | throughout study completion, an average of 7 days |