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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05142969
• Other study ID #: 2020ZSLC69
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Shining Cai, PhD
• Phone: 02164041990
• Email: cai.shining[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 247
• Est. completion date: December 31, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chlorhexidine
• Communicable Diseases
• Cross Infection
• Hospital-Acquired Infection
• Infections
• Intensive Care Unit
• Surgery

Intervention

Other:
• 2% 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.

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hospital-acquired infections	Including bloodstream infections (BSI), central line-associated BSI (CLABSI), ventilator-associated pneumonia (VAP) and catheter-associated urinary tract infection (CAUTI).	throughout study completion, an average of 7 days
Secondary	Multidrug-resistant bacterial colonization free time	Time that the swab samples collected from axilla and groin were persistently negative for target MDR throughout ICU admission.	throughout study completion, an average of 7 days