Chlorhexidine Bathing in Critically Ill Children

September 11, 2026 updated by: Saime Hacer Ozdemir, Istanbul Medeniyet University

Effect of Daily 2% Chlorhexidine Gluconate Bathing on Central Line-Associated Bloodstream Infections in Critically Ill Children: A Single-Center Randomized Controlled Trial

Central line-associated bloodstream infections are associated with increased mortality, morbidity, and length of hospital stay. The incidence has decreased significantly with the strict implementation of preventive bundle cares and checklists in intensive care units. Bathing with solutions containing chlorhexidine has been included in preventive strategies in recent years. Although some studies have shown that chlorhexidine bathing reduces the frequency of hospital-associated infections, there are important differences in management of practice and adherence to practice in different facilities. The majority of the studies conducted include adult patients. According to the CDC guidelines, chlorhexidine bathing is recommended for children over 2 months of age to prevent Central line-associated bloodstream infections. The aim of this study is to investigate the effect of daily bathing with 2% chlorhexidine gluconate solution in preventing Central line-associated bloodstream infections in pediatric patients with temporary central venous catheters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In patients with a central catheter for longer than 48 hours, the diagnosis of bloodstream infection will be recorded as laboratory-confirmed bloodstream infections according to CDC diagnostic criteria. Microorganisms detected in cultures will be classified as gram-positive and gram-negative or fungal agents. Infection with the resistant microorganism will be compared with the control group. Catheter colonization; be defined as bacterial growth of more than 15 colonies in the semiquantitative culture or 1000 colonies in the quantitative culture of the catheter segment or hub without clinical symptoms.

Patients in both groups with a central catheter for longer than 48 hours will be treated with a standard bath every day. In addition to the control group, patients in the study group will be treated daily with 2% chlorhexidine gluconate, and the patients in these two groups will be compared in terms of Central line-associated bloodstream infections and catheter colonization.

Study Type

Interventional

Enrollment (Actual)

247

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients between the ages of 2 months and 18 years who had a temporary central venous catheter
  • Patients whose follow-up is continued for at least 48 hours with a central venous catheter

Exclusion Criteria:

  • Patients younger than 2 months of age
  • Patients with a intensive care unit stay shorter than 48 hours
  • Immunosuppressive patients
  • Patients with a history of allergic reaction to chlorhexidine
  • Patients with skin lesions that interfere with skin cleansing with chlorhexidine
  • Patients whose family did not give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chlorhexidine bathing group
Patients aged between 2 months and 18 years with temporary central venous catheter in the pediatric intensive care unit were recruited. Patients younger than 2 months of age, patients with a catheter use of less than 48 hours, patients with a history of allergic reaction with chlorhexidine, patients with a skin condition that interferes with skin cleansing with chlorhexidine, and immunocompromised patients were excluded from the study. Participants of the study were randomized with a ratio of 1:1. In study group, standard bathing will be applied on the first day of insertion of the central venous catheter, and in addition to that it is planned to clean the skin of the patient daily with cleaning pads impregnated with 2% Chlorhexidine gluconate.
Other: clorhexidine gluconate bathing
daily skin cleansing with chlorhexidine gluconate
Other Names:
  • cathater care practices
No Intervention: standart bathing group
Patients who are included in the study but not intervention group will be treated with standard bathing, which applied in every day in our facility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central line-associated bloodstream infection
Time Frame: 2 years.
The main objective of this research was to perform a randomized controlled trial to evaluate the difference between daily 2% CHG bathing and daily standard soap with water bathing concerning the occurrence of CLABSI in critically ill children in the PICU who had undergone CVC placement.
2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microorganisms that cause catheter colonization in patients which applied standard bathing
Time Frame: 2 years.
The secondary aims were to assess the rate of catheter colonization in both groups and to identify the microorganisms responsible for CLABSI and catheter colonization in this pediatric population.
2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medeniyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

August 12, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0009-0009-3168-4445

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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