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

NCT05142969 | Unknown

• 1 other identifier: 2020ZSLC69
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Multidrug-resistant bacterial colonization free time

  throughout study completion, an average of 7 days

Study Arms (2)

Control arm

NO INTERVENTION

Patients were daily bathed with soap and water only.

Intervention arm

EXPERIMENTAL

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

Interventions

2% Chlorhexidine bathing OTHER

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults (≥ 18-years old)
• anticipated SICU stay for 48 hours or more
• APACHE II \>15

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shining Cai, PhD

CONTACT

02164041990; cai.shining@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 3, 2021
• Study Start: December 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: December 31, 2023
• Last Updated: December 29, 2021

Record last verified: 2021-11

Locations

CN (1)