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

Hospital Infection Clinical Trial

— Duclorexint  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03639363
• Other study ID #: Duclorexint
• Status: Completed
• Phase: Phase 4
• Start date: August 10, 2015
• Est. completion date: May 2, 2016

Study information

• Verified date: August 2018
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: May 2, 2016
• Est. primary completion date: April 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Hospital Infection
• Infection

Intervention

Drug:
• 4% chlorhexidine gluconate soap-like solution
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

Other:
• standard soap
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Of Perugia	Fondazione Toscana Gabriele Monasterio

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ventilator-associated pnemonias (VAP) incidence	VAP incidence	infections occured 48 hours after admission to ICU/PC-ICU
Secondary	Bloodstream infections (BSI) incidence	BSI incidence	infections occured 48 hours after admission to ICU/PC-ICU
Secondary	central-line associated BSI (CLABSI) incidence	CLABSI incidence	infections occured 48 hours after admission to ICU/PC-ICU
Secondary	urinary tract infections (UTI) incidence	UTI incidence	infections occured 48 hours after admission to ICU/PC-ICU
Secondary	catheter associated UTI (CAUTI) incidence	CAUTI incidence	infections occured 48 hours after admission to ICU/PC-ICU
Secondary	4% CHG daily bathing safety	overall mortality in the treatment and control arm	at discharge, approximately up to 10 days
Secondary	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
Secondary	time till infection	time between admission to ICU/PC-ICU and infection occurrence	at discharge, approximately up to 10 days