New tape-care method aims to spare kids' skin in ICUs
NCT ID NCT06122402
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a 'SECURE Care Bundle' to prevent skin injuries caused by medical tape used to hold central venous catheters in place. Researchers compared 46 children who received the bundle (skin checks, risk assessment, proper tape application/removal, and a silicone-based remover) with 46 children who got standard care. The goal was to see if the bundle reduces how often skin injuries happen and delays when they first appear.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SECURE Care Bundle (a systematic approach including skin checks, risk assessment, proper adhesive application and removal, and silicone-based remover)
- What this could lead to
- If effective, this care bundle could become a standard practice to prevent painful skin injuries in hospitalized children with central lines.
- What could go wrong
- This is a small, single-center study with 91 children, so results may not apply to all hospitals or age groups. The bundle adds steps to routine care, which may be harder to implement consistently.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
91 people
The number who actually took part.
- Started
-
Jul 2024
- Finished
-
Apr 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Up to 18 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Skin injury are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Istanbul University- Cerrahpaşa
Istanbul, Şisli, 34116, Turkey (Türkiye)
-
Istanbul University- Cerrahpaşa
Istanbul, Şişli, 34381, Turkey (Türkiye)
More trials for these conditions
Other studies related to the condition(s) this trial covers.