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

NCT06720064 | Recruiting DMC

• 1 other identifier: carebundle
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer

Keywords

Care bundle; chlorhexidine; pediatric; cancer; catheter-related bloodstream infections

Outcome Measures

Primary Outcomes (1)

• Central line-associated bloodstream infections

  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

Study Arms (2)

Control

NO INTERVENTION

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)

Care bundle approach with Chlorhexidine Dressing

EXPERIMENTAL

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

Interventions

Chlorhexidine Dressing DEVICE

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

Care bundle approach with Chlorhexidine Dressing

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Have a systemic infection.

Sponsors & Collaborators

• Dokuz Eylul University: lead
• Afyonkarahisar Health Science University: collaborator

Study Sites (1)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Gulcin Ozalp Gerceker, Assoc. Prof.

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: December 6, 2024
• Study Start: May 7, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)