Effectiveness of Care Bundle in Preventing Medical Adhesive-Related Skin Injury Due to Central Venous Catheter Fixation in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Incidence of medical adhesive-related skin injury due to central venous catheter fixation
研究概览
简要总结
Skin injury due to the use of medical adhesives is a common but under recognized complication in children. To prevent central venous catheter-related complications, care interventions should be planned in such a way that they do not lead to medical adhesive-related skin injury. Systematic administration of preventive care interventions is needed to reduce skin injuries associated with medical adhesive used for central venous catheter fixation. The SECURE Care Bundle has been developed by researchers based on the latest evidence to prevent medical adhesive-related skin injuries associated with central venous catheter fixation in children.The SECURE Care Bundle is a systematic approach to care that includes checking the skin, assessing risk factors, correctly applying and removing medical adhesives and registering medical adhesive related skin injury.
This study aims to evaluate the effectiveness of the SECURE Care Bundle in reducing MARSI incidence related to CVC fixation in pediatric patients and to examine its influence on the MARSI occurrence time.
Hypotheses Null Hypothesis (H₀): There is no effect of the SECURE Care Bundle in preventing skin injuries related to central venous catheter (CVC) fixation in children.
Hypothesis 1 (H₁): Children who receive the SECURE Care Bundle experience a lower incidence of medical adhesive-related skin injury due to CVC fixation compared to those who receive standard care.
Hypothesis 2 (H₂): Children who receive the SECURE Care Bundle develop medical adhesive-related skin injury due to CVC fixation later than those who receive standard care.
This quasi-experimental study follows a pre-test/post-test control group design and will be conducted in the Pediatric Cardiovascular Intensive Care Unit. A total of 92 pediatric patients will participate. Following informed consent, patients will be allocated into intervention (n=46) and control (n=46) groups. Data collection tools will include a descriptive information form, the Braden QD Scale, a skin observation form, and the SECURE Care Bundle checklist. The intervention group will receive the SECURE Care Bundle, and its effectiveness will be assessed by analyzing MARSI incidence and time to onset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Participant)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 0 to 18 years.
- •Underwent cardiovascular surgery and had a jugular central venous catheter (CVC) inserted.
- •Admitted to the Pediatric Cardiovascular Intensive Care Unit (PCCU) in the postoperative period.
- •Have a Braden QD Scale score of 12 or higher at admission.
- •Parental informed consent obtained via a voluntary participation form.
排除标准
- •Patients who had a central venous catheter inserted in another unit prior to cardiovascular surgery.
- •Patients with pre-existing skin injury around the catheter site before insertion.
- •Patients with a known history of dermatological disease.
- •Patients with a known allergy to any of the products used in the study.
- •Patients for whom catheter leakage occurs.
- •Patients whose catheter is removed due to complications (e.g., infection, dislodgement, or other clinical reasons).
研究组 & 干预措施
SECURE Care Bundle
The SECURE Care Bundle has been developed by researchers based on the latest evidence to prevent medical adhesive-related skin injuries associated with central venous catheter fixation in children. The SECURE Care Bundle is a systematic approach to care that includes checking the skin, assessing risk factors, correctly applying and removing medical adhesives and registering medical adhesive related skin injury.
干预措施: SECURE Care Bundle (Other)
Standart Care
No intervention will be applied to this group. No intervention will be applied to this group. The care provided in the clinic will continue to be provided in the same way.
干预措施: Standart Care (Procedure)
结局指标
主要结局
Incidence of medical adhesive-related skin injury due to central venous catheter fixation
时间窗: From Day 1 (postoperative admission to PCCU) to MARSI occurrence or discharge, up to 30 days
Incidence of medical adhesive-related skin injury due to central venous catheter fixation refers to the proportion of patients who develop medical adhesive-related skin injury (MARSI). This outcome will be assessed in both the pre-test and post-test groups, and the results will be compared to evaluate the effectiveness of the intervention.Three types of MARSI incidence rates will be calculated: (1)the rate per 100 patients, (2)the rate per 100 MAs, and (3)the rate per 1000 days of MA use. The formulas for calculating each incidence rate will be as follows: (1)incidence rate per 100 patients= number of MARSIs/number of patients × 100, (2)incidence rate per 100 MAs= number of MARSIs/number of MAs × 100, and (3)incidence rate per 1000 days of MA use= number of MARSIs/number of days of MA usage × 1000.
次要结局
- MARSI occurrence time(From Day 1 (the day of CVC insertion and fixation) to the first occurrence of MARSI or end of treatment, up to 30 days)
研究者
Özlem Şensoy
Principal Investigator
Istanbul University - Cerrahpasa