Clinical trial NCT06720064: Care Bundle Containing Chlorhexidine Dressing on Port Catheter and Central Venous Catheters
Official title: Care Bundle Containing Chlorhexidine Dressing on Port Catheter and Central Venous Catheter-Related Bloodstream Infections in Pediatric Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Keywords: Care bundle
chlorhexidine
pediatric
cancer
catheter-related bloodstream infections
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Afyonkarahisar Health Science University
First posted: 2024-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Central line-associated bloodstream infections
timeFrame: during the intervention, up to 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gülçin Özalp Gerçeker
Study officials:
affiliation: Dokuz Eylul University
name: Gulcin Ozalp Gerceker, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: