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

Last updated: May 6, 2025
Sponsor: Istanbul University - Cerrahpasa
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pressure Ulcer

Treatment

Standart Care

SECURE Care Bundle

Clinical Study ID

NCT06122402
IUC-SENSOY-MARSI-001
  • Ages < 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thepostoperative period.

  • Have a Braden QD Scale score of 12 or higher at admission.

  • Parental informed consent obtained via a voluntary participation form.

Exclusion

Exclusion Criteria:

  • Patients who had a central venous catheter inserted in another unit prior tocardiovascular 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).

Study Design

Total Participants: 92
Treatment Group(s): 2
Primary Treatment: Standart Care
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Istanbul University- Cerrahpaşa

    Istanbul, Şişli 34381
    Turkey

    Active - Recruiting

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