Clinical trial NCT06122402: Effectiveness of Care Bundle in Preventing Medical Adhesive-Related Skin Injury Due to Central Venous Catheter Fixation in Children
Official title: Effectiveness of Care Bundle in Preventing Medical Adhesive-Related Skin Injury Due to Central Venous Catheter Fixation in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Injury
Keywords: children
marsi
medical adhesive-related skin injury
care bundle
skin injury
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2023-11-08
Enrollment: 92
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is designed as a quasi-experimental study with a pre-test and post-test control group design.
Primary purpose: PREVENTION

Brief 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: 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).

Primary outcomes:
measure: 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
Secondary outcomes:
measure: MARSI occurrence time
timeFrame: From Day 1 (the day of CVC insertion and fixation) to the first occurrence of MARSI or end of treatment, up to 30 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpaşa
state: Şişli
Study officials:
References: