Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06720064

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pediatric Cancer Neoplasms

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gülçin Ö Gerçeker

CONTACT

[email protected]

05306411368

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chlorhexidine Dressing

Device

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

Primary outcomes

  1. Central line-associated bloodstream infections

    Time frame: during the intervention, up to 1 years

    defined as the recovery of a pathogen from a blood culture in a patient who had a central line at the time of infection or within 48 hours before the development of infection

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Collaborators

  • Afyonkarahisar Health Sciences University

Registry information

Official study title

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

Acronym: CHG-port

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.