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Recruiting NCT06720064

Care Bundle Containing Chlorhexidine Dressing on Port Catheter and Central Venous Catheters

No phase Interventional Pediatric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chlorhexidine Dressing.
Who it may be relevant to
Registry conditions: Pediatric Cancer. Basic parameters: 1 year — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Care Bundle Containing Chlorhexidine Dressing on Port Catheter and Central Venous Catheter-Related Bloodstream Infections in Pediatric Cancer Patients

Overview

In order to provide treatment in pediatric hematology-oncology patients, in some cases a central venous catheter is required in children. The most important situation to pay attention to when using a central venous catheter is "Central line-associated bloodstream infections". These infections are infections that develop after admission to the hospital and are not in the incubation period at the time of admission, or although they usually develop in the hospital 48-72 hours after hospitalization, they can sometimes appear after discharge. Central line-associated bloodstream infections significantly increase morbidity and mortality. In this context, the effect of using a care bundle containing chlorhexidine dressing on port catheter and central venous catheter-related bloodstream infections in pediatric cancer patients was examined.

Detailed description

This study was designed as a prospective, cross-sectional, and randomized controlled study to examine the effect of a care package containing chlorhexidine dressing on port catheter and central venous catheter-related bloodstream infections in pediatric cancer patients.

Hypotheses of the Research H1: Care bundle approach including chlorhexidine dressing in pediatric cancer patients reduces port catheter and central venous catheter-related bloodstream infections.

H2: Care bundle approach including chlorhexidine dressing in pediatric cancer patients reduces port catheter and central venous catheter-related complications.

Randomization A stratified randomization scheme was used to distribute the sample into groups. Stratification randomization was made according to port catheter stay duration, age group, hematological/oncological cancer type and hematopoietic stem cell transplantation unit / pediatric hematology and oncology clinic.

Interventions

  • Device Chlorhexidine Dressing
    Transparent catheter cover with Chlorhexidine (3M™ CHG Tegaderm™)

Primary outcome measures

  • Central line-associated bloodstream infections [Time frame: during the intervention, up to 1 years]

Eligibility criteria

Inclusion criteria

  • The child is receiving inpatient treatment at the Hematology and Oncology unit and hematopoietic stem cell transplantation unit
  • The child has a diagnosis of hematological or oncological cancer
  • The child's age range is between 1 and 17
  • Having a port catheter inserted and no early complications have occurred
  • The child agrees to participate in the study voluntarily
  • The parent agrees to participate in the study voluntarily
  • Obtaining the consent form from the child and parent
  • He has been in the hospital for more than 48 hours

Exclusion criteria

  • Have a systemic infection.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Gülçin Özalp Gerçeker — Izmir

Identifiers

NCT: NCT06720064 · carebundle

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗