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

Phase 4

Completed

• Conditions: Hospital Infection
• Interventions: Drug: 4% chlorhexidine gluconate soap-like solution; Other: standard soap

• Registration Number: NCT03639363
• Lead Sponsor: University Of Perugia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-10
• Primary Completion: 2016-04-28
• Study Completion: 2016-05-02
• Status Verified: 2018-08
• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-17
• Last Update Submitted: 2018-08-17
• Study First Posted: 2018-08-21
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 449

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	4% chlorhexidine gluconate soap-like solution	daily bathing with 4% chlorhexidine gluconate soap-like solution followed by water rinsing
Control Arm	standard soap	daily bathing with standard soap

Primary Outcome Measures

Name	Time	Method
hospital acquired infections incidence	infections occured 48 hours after admission to ICU/PC-ICU	cumulative incidence of bloodstream infections (BSI), central line-associates BSI (CLABSI), urinary tract infections (UTI), catheter-associated UTI (CAUTI) and ventilator-associated pneumonias (VAP)

Secondary Outcome Measures

Name	Time	Method
Ventilator-associated pnemonias (VAP) incidence	infections occured 48 hours after admission to ICU/PC-ICU	VAP incidence
Bloodstream infections (BSI) incidence	infections occured 48 hours after admission to ICU/PC-ICU	BSI incidence
central-line associated BSI (CLABSI) incidence	infections occured 48 hours after admission to ICU/PC-ICU	CLABSI incidence
catheter associated UTI (CAUTI) incidence	infections occured 48 hours after admission to ICU/PC-ICU	CAUTI incidence
urinary tract infections (UTI) incidence	infections occured 48 hours after admission to ICU/PC-ICU	UTI incidence
4% CHG daily bathing safety	at discharge, approximately up to 10 days	overall mortality in the treatment and control arm
4% CHG daily bathing-related adverse events	at discharge, approximately up to 10 days	4% CHG daily bathing-related adverse events in the treatment arm compared to standard soap-related adverse events
time till infection	at discharge, approximately up to 10 days	time between admission to ICU/PC-ICU and infection occurrence