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Chlorhexidine Bathing in Critically Ill Children

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05995080
Enrollment
247
Registered
2023-08-16
Start date
2023-05-01
Completion date
2025-05-01
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bloodstream Infection Due to Central Venous Catheter, Central Line-associated Bloodstream Infections

Keywords

chlorhexidine gluconate, Central line-associated bloodstream infection

Brief summary

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.

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.

Interventions

OTHERclorhexidine gluconate bathing

daily skin cleansing with chlorhexidine gluconate

Sponsors

Istanbul Medeniyet University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

The control and study groups were determined by applying randomization at a ratio of 1:1 to the patients which participated to the study.

Intervention model description

The control and study groups were determined by applying randomization at a ratio of 1:1 to the patients which participated to the study.

Eligibility

Sex/Gender
ALL
Age
2 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Central line-associated bloodstream infection2 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.

Secondary

MeasureTime frameDescription
Microorganisms that cause catheter colonization in patients which applied standard bathing2 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026