Care Bundle Containing Chlorhexidine Dressing on Port Catheter and Central Venous Catheter-Related Bloodstream Infections in Pediatric Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Central line-associated bloodstream infections
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Have a systemic infection.
研究组 & 干预措施
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)
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)
干预措施: Chlorhexidine Dressing (Device)
结局指标
主要结局
Central line-associated bloodstream infections
时间窗: 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
次要结局
未报告次要终点
研究者
Gülçin Özalp Gerçeker
Assoc. Prof.
Dokuz Eylul University