Skin InjuryNCT06122402

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

A study testing SECURE Care Bundle and Standart Care in people with Skin Injury, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 18 years
Conditions the study is for: Skin Injury
What is being tested?: SECURE Care Bundle and Standart Care
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 2 sitesTurkey (Türkiye)
Study dates: 1 Jul 2024to 30 Apr 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

Istanbul University- Cerrahpaşa
Istanbul, Şisli, 34116
Istanbul University- Cerrahpaşa
Istanbul, Şişli, 34381

Other trials in Turkey (Türkiye)

About this study

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.

Conditions: Skin Injury
Being tested: SECURE Care Bundle, Standart Care
Keywords: children, marsi, medical adhesive-related skin injury, care bundle, skin injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SECURE Care BundleOther
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.
Standart CareProcedure or surgery
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.

Study groups in NCT06122402
Study group	Role	What they receive
SECURE Care Bundle	Experimental	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. Receives: Other: SECURE Care Bundle
Standart Care	Active comparator	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. Receives: Procedure: Standart Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of medical adhesive-related skin injury due to central venous catheter fixation
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.
Measured: From Day 1 (postoperative admission to PCCU) to MARSI occurrence or discharge, up to 30 days

Secondary outcomes (1)

MARSI occurrence time
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.
Measured: From Day 1 (the day of CVC insertion and fixation) to the first occurrence of MARSI or end of treatment, up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202430 Apr 2025

First posted8 Nov 2023
Study start1 Jul 2024
Primary completion30 Apr 2025
Study completion30 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Skin InjuryStudies of the same condition, open and under way.
More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: The study is designed as a quasi-experimental study with a pre-test and post-test control group design.
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06122402
Sponsor's protocol ID: IUC-SENSOY-MARSI-001
Status last verified: Nov 2025
First submitted: 5 Nov 2023
Last updated: 25 Nov 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Study Protocol and Statistical Analysis Plan will be provided.

Publications

Sensoy O, Caglar S. SECURE Care Bundle to Prevent Medical Adhesive-Related Skin Injury in Paediatric Central Venous Catheter Fixation: A Study Protocol. Nurs Crit Care. 2025 Nov;30(6):e70226. doi: 10.1111/nicc.70226.
PubMed 41193400

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Care Bundle in Preventing Medical Adhesive-Related Skin Injury Due to Central Venous Catheter Fixation in Children
ClinicalTrials.gov ID: NCT06122402
Acronym / sponsor ID: IUC-SENSOY-MARSI-001
Conditions: Skin Injury
Keywords: children, marsi, medical adhesive-related skin injury, care bundle, skin injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Istanbul University - CerrahpasaUniversity, hospital or other
Collaborators: The Scientific and Technological Research Council of Turkey
Study start: 1 Jul 2024 (actual)
Primary completion: 30 Apr 2025 (actual)
Study completion: 30 Apr 2025 (actual)
First posted: 8 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: The study is designed as a quasi-experimental study with a pre-test and post-test control group design.

Arm	Type	Receives
SECURE Care Bundle	Experimental	Other: SECURE Care BundleThe 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.
Standart Care	Active comparator	Procedure: Standart CareNo 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.

Who may qualify

Ages: Up to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SECURE Care BundleThe 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.	Other	SECURE Care Bundle
Standart CareIt 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.	Procedure or surgery	Standart Care

Primary outcome

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.

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
Derived from this study: PubMed 41193400Sensoy O, Caglar S. SECURE Care Bundle to Prevent Medical Adhesive-Related Skin Injury in Paediatric Central Venous Catheter Fixation: A Study Protocol. Nurs Crit Care. 2025 Nov;30(6):e70226. doi: 10.1111/nicc.70226.
Individual participant dataSharing planned: Yes. Study Protocol and Statistical Analysis Plan will be provided.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Özlem Şensoy principal investigator

İstanbul University-Cerrahpaşa

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SECURE Care Bundle and Standart Care in people with Skin Injury, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06122402, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.