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

Study Overview
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Brief Summary
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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. The goal of this randomized controlled trial study is to evaluate about SECURE care bundle in preventing medical adhesive-related skin injury due to central venous catheter fixation in children. The main questions it aims to answer are Is the SECURE Care Bundle effective in reducing the incidence of medical adhesive-related skin injuries due to central venous catheter fixation? Does the SECURE Care Bundle have an effect on the first central venous catheter dressing change time? Data will collect after the parents of the children who meet the case selection criteria will inform about the research, their oral and written consents will be obtained through the Informed Consent Form. Researchers will compare the SECURE Care Bundle group to the standard care group to see medical adhesive-related skin injury due to central venous catheter fixation.

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

Conditions
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Skin Injury

Intervention / Treatment
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* Other: SECURE Care Bundle
* Procedure: Standart Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The child is being treated with a central venous catheter (CVC) in the intensive care unit 28 days to 5 years old Patients with a Braden Q score of intermediate risk and above will be included in the study. Exclusion Criteria: Children without CVC, Children with previous skin and tissue damage in the area where CVC will be opened, Children with allergies to the products used Patients who are already receiving treatment with CVC at the beginning of the study periods will not be included in the study.

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SECURE Care Bundle<br>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. | Other: SECURE Care Bundle<br>* 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 2-octyl-cyanoacrylate tissue adhesive, CHG dressing and silicone based remover.<br>* Other names: SecurePort IV, 2-octyl-cyanoacrylate tissue adhesive;|
| Active Comparator: Standart Care<br>No intervention will be applied to this group. No intervention will be applied to this group. The care provided in the clinic will continue to be provided in the same way. | Procedure: Standart Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low incidence of medical adhesive-related skin injury due to central venous catheter fixation | Reducing the incidence of medical adhesive-related skin injury due to central | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longer initial central venous catheter dressing change time | First central venous catheter dressing change time being longer compared to the control group | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, marsi, medical adhesive-related skin injury, care bundle, skin injury