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

Not Applicable

• Conditions: Hospital-Acquired Infection; Surgery; Chlorhexidine; Intensive Care Unit
• Interventions: Other: 2% Chlorhexidine bathing

• Registration Number: NCT05142969
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-21
• Study Start: 2021-12-01
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-03
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2021-12-29
• Primary Completion: 2023-03-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 247

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	2% Chlorhexidine bathing	Patients were daily bathed with soap and water and then receive 2% Chlorhexidine bathing (Petel Skin care wipes, Likang LtD, shanghai, China).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China