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

Not Applicable

Recruiting

• Conditions: Pediatric Cancer

• Registration Number: NCT06720064
• Lead Sponsor: Dokuz Eylul University

Brief Summary

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.

Study Timeline

• Study Start: 2024-05-07
• Study First Submitted: 2024-09-18
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Central line-associated bloodstream infections	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

Trial Locations

Locations (1)

Gülçin Özalp Gerçeker; 🇹🇷 İzmir, Turkey