Care Bundle Containing Chlorhexidine Dressing on Port Catheter and Central Venous Catheters (CHG-port)

December 5, 2024 updated by: Gülçin Özalp Gerçeker, Dokuz Eylul University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

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

  • Turkey
      • İzmir, Turkey, 35100
        • Recruiting
        • Gülçin Özalp Gerçeker
        • Contact:

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

Accepts Healthy Volunteers

No

Description

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 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control

Standard care bundle approach; The following materials will be used by nurses while performing their care in accordance with the relevant care bundle and checklist;

  • Transparent catheter cover (3M™ IV-Tegaderm™) (Control group)
  • Needle-free interventional apparatus (BD Qsyte split septum™),
  • Prefilled flush syringe (BD PosiFlush™)
  • Alcohol swab (alcohol cloth),
  • Solupred Swab (3M™), (will be used to clean the dressing area)
Experimental: Care bundle approach with Chlorhexidine Dressing

Care bundle approach with Chlorhexidine Dressing The following materials will be used by nurses while performing their care in accordance with the relevant care bundle and checklist;

  • Transparent catheter cover with Chlorhexidine (3M™ CHG Tegaderm™) (Study group)
  • Needle-free interventional apparatus (BD Qsyte split septum™),
  • Prefilled flush syringe (BD PosiFlush™)
  • Alcohol swab (alcohol cloth),
  • Solupred Swab (3M™), (will be used to clean the dressing area)
Device: Chlorhexidine Dressing
Transparent catheter cover with Chlorhexidine (3M™ CHG Tegaderm™)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during the intervention, up to 1 years

Collaborators and Investigators

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

Sponsor

Dokuz Eylul University

Collaborators

Afyonkarahisar Health Science University

Investigators

  • Principal Investigator: Gulcin Ozalp Gerçeker, Assoc. Prof., Dokuz Eylül University

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 7, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Estimated)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • carebundle

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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