Care Bundle for Prevention of Skin Complications and Edema in Restrained Patients (SCER-ICU)

February 27, 2026 updated by: Pinar Erman, Kocaeli City Hospital

Development and Evaluation of the Effectiveness of a Dermatological Complications and Edema Prevention Care Package in the Physical Constraint Zone

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.).

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Care Bundle
Participants in this group will receive structured dermatological complications and an Edema Prevention Care Package in the physical restraint area, in addition to routine nursing care in the intensive care unit.The care package group includes: assessment of the area of physical restraint, application of physical restraint to the upper extremities (both wrists), massage, and elevation.
Other: Evulation
  1. Consent is obtained from the patient's relatives for the application of physical restraint/the consent obtained is verified.
  2. Before initiating physical restraint and every 2 hours during the period of physical restraint, the restraint area is assessed for laseration, ulceration, ecchymosis, erythema, numbness, pain, increased temperature, color change, capillary refill time, and fluctuations in peripheral pulse, and the findings are recorded.
  3. If any of these findings are present, the physician is notified and physical restraint is not applied.
  4. If any of these findings develop during the period of physical restraint, the physician is notified, physical restraint is discontinued, and the finding is recorded.
  5. The indication for restraint is reviewed every 8 hours.
Other: Application of physical restraint material
  1. Physical restraint is performed using a single-use restraint bandage.
  2. The bandage is wrapped around the patient's wrist, adjusting the distance between the bandage and the wrist to 2 cm (approximately 2 fingers' width).
  3. The ties of the restraint bandage are secured to the bed rail at a point that the patient cannot reach or untie.
  4. If there is an arterial catheter/peripheral venous catheter in the restraint area, the restraint material is placed so as not to apply pressure to these lines to ensure the safety of the area and preserve vascular integrity; the flow and patency of the lines are checked at regular intervals during restraint.
Other: Elevation
  1. While physical restriction continues, elevation at a 30-degree angle is applied to the restricted area 5 times a day, for 30 minutes each time.
  2. Elevation is applied by placing the forearm (the area between the elbow and fingertips) on the elevation pillow while the patient is lying on their back or side.
  3. The elbow is placed at the lowest angle point between the elevation pillow and the floor, and the fingertips are placed at the highest angle point.
  4. The patient's safety and the maintenance of the extremity position are assessed hourly during the elevation period.
Other: Hand massage
  1. While the physical restriction continues, the restriction band is loosened and a hand massage is applied to the restricted hand once a day for 15 minutes each time.
  2. Before starting the massage, moisturizing cream is applied to the physically restricted area, followed by stroking and kneading exercises from distal to proximal in the direction of the heart.
  3. The massage begins with light pressure, which is gradually increased.
No Intervention: routine care
Participants in this group will receive routine intensive care unit nursing care without implementation of the structured care bundle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
edema, ecchymosis, laceration, ulceration
Time Frame: From the initiation of physical restraint to the 5th day.
The rates of edema, ecchymosis, laceration and ulceration developing in the restricted area in the days following physical restriction.
From the initiation of physical restraint to the 5th day.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kocaeli City Hospital

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient data will only be used for statistical analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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