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

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05142969

Collaborator

(none)

247

Enrollment

Location

Arms

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chlorhexidine Hospital-Acquired Infection Surgery Intensive Care Unit	Other: 2% Chlorhexidine bathing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

247 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control arm Patients were daily bathed with soap and water only.
Experimental: Intervention arm Patients were daily bathed with soap and water and then receive 2% Chlorhexidine bathing (Petel Skin care wipes, Likang LtD, shanghai, China).	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.

Arm

Intervention/Treatment

No Intervention: Control arm

Patients were daily bathed with soap and water only.

Experimental: Intervention arm

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

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Zhongshan Hospital

ClinicalTrials.gov Identifier:

NCT05142969

Other Study ID Numbers:

2020ZSLC69

First Posted:

Dec 3, 2021

Last Update Posted:

Dec 29, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Cross Infection

Chlorhexidine

Study Results

No Results Posted as of Dec 29, 2021