CompletedNot Applicable

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

Turkey (Türkiye)91 participantsStarted 2024-07-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of medical adhesive-related skin injury due to central venous catheter fixation

Timeframe: From Day 1 (postoperative admission to PCCU) to MARSI occurrence or discharge, up to 30 days

Trial details

NCT IDNCT06122402

SponsorIstanbul University - Cerrahpasa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Skin Injury trials