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

November 20, 2025 updated by: Özlem Şensoy, Istanbul University - Cerrahpasa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Şisli
      • Istanbul, Şisli, Turkey (Türkiye), 34116
        • Istanbul University- Cerrahpasa
    • Şişli
      • Istanbul, Şişli, Turkey (Türkiye), 34381
        • Istanbul University- Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SECURE Care Bundle
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
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 CHG dressing and silicone based remover.
Active Comparator: Standart Care
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of medical adhesive-related skin injury due to central venous catheter fixation
Time Frame: From Day 1 (postoperative admission to PCCU) to MARSI occurrence or discharge, up to 30 days
Incidence of medical adhesive-related skin injury due to central venous catheter fixation refers to the proportion of patients who develop medical adhesive-related skin injury (MARSI). This outcome will be assessed in both the pre-test and post-test groups, and the results will be compared to evaluate the effectiveness of the intervention.Three types of MARSI incidence rates will be calculated: (1)the rate per 100 patients, (2)the rate per 100 MAs, and (3)the rate per 1000 days of MA use. The formulas for calculating each incidence rate will be as follows: (1)incidence rate per 100 patients= number of MARSIs/number of patients × 100, (2)incidence rate per 100 MAs= number of MARSIs/number of MAs × 100, and (3)incidence rate per 1000 days of MA use= number of MARSIs/number of days of MA usage × 1000.
From Day 1 (postoperative admission to PCCU) to MARSI occurrence or discharge, up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MARSI occurrence time
Time Frame: From Day 1 (the day of CVC insertion and fixation) to the first occurrence of MARSI or end of treatment, up to 30 days
MARSI occurrence time is defined as the time interval, measured in days, from the initial application of the central venous catheter (CVC) and its securement with medical adhesive to the first documented occurrence marsi.
From Day 1 (the day of CVC insertion and fixation) to the first occurrence of MARSI or end of treatment, up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa

Collaborators

The Scientific and Technological Research Council of Turkey

Investigators

  • Principal Investigator: Özlem Şensoy, Istanbul University-Cerrahpaşa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

November 5, 2023

First Submitted That Met QC Criteria

November 5, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUC-SENSOY-MARSI-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol and Statistical Analysis Plan will be provided.

IPD Sharing Time Frame

The data will be become available upon request for three years.

IPD Sharing Access Criteria

The data will become available upon request by contacting with principle investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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