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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05142969

Enrollment

247

Registered

2021-12-03

Start date

2021-12-01

Completion date

2023-12-31

Last updated

2021-12-29

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

Conditions

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

Brief summary

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.

Interventions

OTHER2% Chlorhexidine bathing

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactShining Cai, PhD

cai.shining@zs-hospital.sh.cn02164041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026