Care Bundle for Prevention of Skin Complications and Edema in Restrained Patients

Starting soon · Not applicable

Conditions studied: Edema, Dermatologic Complication, Physical Restraints

In brief

Physical restraint (restraint) is defined as the restriction of a patient's free body movements and the prevention of the patient's ability to move easily by healthcare professionals using physical or mechanical devices to prevent the patient from harming themselves or others. Physical restraints can be used by healthcare professionals for many purposes, particularly in intensive care units, such as ensuring patient safety, controlling aggressive and disruptive behavior, continuing patient care and treatment, and preventing the removal of medical equipment attached to the patient. However, when looking at the duration of physical restraint applications, it has been determined that they vary between 3-4 days. The longer the duration of physical restraint, the greater the likelihood of complications developing. In particular, long-term physical restraint can result in neurovascular and dermatological complications such as pressure injuries, edema, ecchymosis, redness, numbness, limited movement, increased temperature, discoloration, and nerve damage. The care package application is a model that improves patient care quality by simultaneously and comprehensively implementing 3-5 applications based on strong scientific evidence, prepared for the relevant area in the specified patient group. Care package applications are created to enable evidence-based practices outlined in guidelines to be used more effectively and practically in clinical settings. Within this context, the aim of this study is to develop a care package to prevent dermatological complications and edema that may occur in the restraint area in patients undergoing physical restraint in intensive care and to evaluate the effectiveness of this care package.

Key facts

Study ID: NCT07442344
Run by: Kocaeli City Hospital
People needed: 76
Starts: 2026-03-01
Expected to finish: 2027-04-01
Last updated by the study team: 2026-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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.).

Where it is running

Kocaeli City Hospital — Kocaeli, Izmit, Turkey (Türkiye)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.