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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03639363

Acronym

Duclorexint

Enrollment

449

Registered

2018-08-21

Start date

2015-08-10

Completion date

2016-05-02

Last updated

2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospital Infection

Keywords

4% chlorhexidine gluconate, infection control

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.

Interventions

DRUG4% chlorhexidine gluconate soap-like solution

1. humidify the whole body surface with the exception of the face using water-impregnated washcloths 2. 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 3. wait for at least 30 seconds 4. rinse using water-impregnated washcloths

OTHERstandard soap

1. humidify the whole body surface with the exception of the face using water-impregnated washcloths 2. use standard soap-impregnated washcloths to bath the whole body surface with the exception of the face 3. wait for at least 30 seconds 4. rinse using water-impregnated washcloths

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
central-line associated BSI (CLABSI) incidence	infections occured 48 hours after admission to ICU/PC-ICU	CLABSI incidence
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
urinary tract infections (UTI) incidence	infections occured 48 hours after admission to ICU/PC-ICU	UTI incidence
catheter associated UTI (CAUTI) incidence	infections occured 48 hours after admission to ICU/PC-ICU	CAUTI 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026