NCT06122402

Effectiveness of Care Bundle in Preventing Medical Adhesive-Related Skin Injury Due to Central Venous Catheter Fixation in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Skin Injury

Interventions

Type	Name	Description
OTHER	SECURE Care Bundle	The SECURE Care Bundle is a systematic approach to care that includes checking the skin, assessing risk factors, registering medical adhesive related skin injury and correctly applying and removing medical adhesives including CHG dressing and silicone based remover.
PROCEDURE	Standart Care	It is applied in routine care in the clinic. There is no standardization and no procedure for checking the skin, assessing risk factors, registering medical adhesive related skin injury and correctly applying and removing medical adhesives. Only CHG dressing is used for central venous catheter care.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2023-11-08
• Last updated: 2025-11-25

Locations

2 sites across 1 country: Turkey (Türkiye)