New care package aims to prevent Restraint-Related skin damage in ICU patients
NCT ID NCT07442344
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to develop and test a care package to prevent skin complications and swelling in intensive care unit patients who require physical restraints. The researchers will compare the rates of skin issues like redness, bruising, and swelling between patients receiving the care package and those receiving standard care. The goal is to improve patient comfort and safety during restraint use.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 76 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * • 18 years of age or older, * For whom a physician has decided to apply physical restraint to the upper extremities and is about to begin doing so, * With intact skin integrity in the area of physical restraint (no lacerations, wounds, ulcerations), * Without oedema in the area of physical restraint, * APACHE-2 score of 17 or higher (In the study by Tian et al. (2022), an APACHE-II score of 17 or higher was found to be associated with a low life expectancy), * Individuals for whom written consent has been obtained from the patient's relatives regarding participation in the study. Exclusion Criteria: * In the physical restraint area; * Those with fractures or dislocations, * Those with peripheral vascular disease or chronic venous insufficiency, * Those with advanced skin disease (psoriasis, etc.), * Those whose physical restraint was discontinued within the first 24 hours after it began for any reason (discharge, transfer to another clinic, death, lifting of the physical restraint decision by the physician, etc.).
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Kocaeli City Hospital
Kocaeli, Izmit, Turkey (Türkiye)
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