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

NCT ID: NCT06720064

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-07

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Pediatric Cancer

Keywords

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Care bundle chlorhexidine pediatric cancer catheter-related bloodstream infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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)

Group Type NO_INTERVENTION

No interventions assigned to this group

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)

Group Type EXPERIMENTAL

Chlorhexidine Dressing

Intervention Type DEVICE

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

Interventions

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Chlorhexidine Dressing

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Afyonkarahisar Health Science University

UNKNOWN

Sponsor Role collaborator

Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Gülçin Özalp Gerçeker

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gulcin Ozalp Gerceker, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

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Gülçin Özalp Gerçeker

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Gülçin Ö Gerçeker

Role: primary

Other Identifiers

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carebundle

Identifier Type: -

Identifier Source: org_study_id