Preventing skin injuries in children from central venous catheters
Effectiveness of Care Bundle in Preventing Medical Adhesive-Related Skin Injury Due to Central Venous Catheter Fixation in Children
This study is testing a new care plan to see if it can help prevent skin injuries in children who have central venous catheters after heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 0 Days to 18 Years |
| Sex | All |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 1 site (Istanbul, Şişli) |
| Trial ID | NCT06122402 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the SECURE Care Bundle, a systematic approach designed to prevent medical adhesive-related skin injuries (MARSIs) in children following central venous catheter (CVC) fixation. The care bundle includes interventions such as skin checks, risk assessments, and proper application and removal of medical adhesives. By implementing these preventive measures, the study aims to reduce the incidence of skin injuries associated with CVCs in pediatric patients. Participants will be children aged 0 to 18 years who have undergone cardiovascular surgery and have a CVC inserted.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 18 years who have undergone cardiovascular surgery and have a jugular central venous catheter inserted postoperatively.
Not a fit: Patients with pre-existing skin injuries, known dermatological diseases, or allergies to study products may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of skin injuries in pediatric patients, improving their overall recovery experience.
How similar studies have performed: While this specific approach is novel, similar studies have shown promise in reducing skin injuries related to medical adhesives in other patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility Criteria: * 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. Exclusion Criteria: * 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).
Where this trial is running
Istanbul, Şişli
- Istanbul University- Cerrahpaşa — Istanbul, Şişli, Turkey (Recruiting)
Study contacts
- Study coordinator: Özlem Şensoy, Ms.c.
- Email: ozlem.sensoy@istanbul.edu.tr
- Phone: +905070076805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.