Pediatric CancerCHG-portNCT06720064
Care Bundle Containing Chlorhexidine Dressing on Port Catheter and Central Venous Catheters
A study testing Chlorhexidine Dressing in people with Pediatric Cancer, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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". Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Chlorhexidine Dressing
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 May 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Have a systemic infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gülçin Özalp Gerçeker
Izmir, 35100
Gülçin Ö Gerçeker, 05306411368, gulcinozalp@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Cancer
- Being tested
- Chlorhexidine Dressing
- Keywords
- Care bundle, chlorhexidine, pediatric, cancer, catheter-related bloodstream infections
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine DressingDevice
Transparent catheter cover with Chlorhexidine (3M™ CHG Tegaderm™)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Chlorhexidine Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the intervention, up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start7 May 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- Afyonkarahisar Health Sciences University
- Responsible party
- Principal investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Gulcin Ozalp Gerceker, Assoc. Prof., Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720064
- Sponsor's protocol ID
- carebundle
- Acronym
- CHG-port
- Status last verified
- Dec 2024
- First submitted
- 18 Sep 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Bundle Containing Chlorhexidine Dressing on Port Catheter and Central Venous Catheter-Related Bloodstream Infections in Pediatric Cancer Patients
- ClinicalTrials.gov ID
- NCT06720064
- Acronym / sponsor ID
- CHG-port / carebundle
- Conditions
- Pediatric Cancer
- Keywords
- Care bundle, chlorhexidine, pediatric, cancer, catheter-related bloodstream infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- Afyonkarahisar Health Sciences University
- Study start
- 7 May 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Chlorhexidine DressingCare 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) |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Have a systemic infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine DressingTransparent catheter cover with Chlorhexidine (3M™ CHG Tegaderm™) | Device | Care bundle approach with Chlorhexidine Dressing |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gulcin Ozalp Gerceker, Assoc. Prof. principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine Dressing in people with Pediatric Cancer, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central line-associated bloodstream infections (time frame: during the intervention, up to 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.