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NCT Number: NCT07442344

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

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.

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Key information

Conditions

Edema Blood Coagulation Disorders Dermatologic Complication Ecchymosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Restraints Signs and Symptoms Skin Manifestations Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli City Hospital

Kocaeli, Izmit, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Evulation

Other
  • Consent is obtained from the patient's relatives for the application of physical restraint/the consent obtained is verified.
  • 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.
  • If any of these findings are present, the physician is notified and physical restraint is not applied.
  • 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.
  • The indication for restraint is reviewed every 8 hours.

Application of physical restraint material

Other
  • Physical restraint is performed using a single-use restraint bandage.
  • 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).
  • The ties of the restraint bandage are secured to the bed rail at a point that the patient cannot reach or untie.
  • 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.

Elevation

Other
  • 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.
  • 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.
  • 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.
  • The patient's safety and the maintenance of the extremity position are assessed hourly during the elevation period.

Hand massage

Other
  • 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.
  • 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.
  • The massage begins with light pressure, which is gradually increased.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşe Ozkaraman, Professor

CONTACT

[email protected]

+90 239 375 0154 ext. 8

pınar erman, PhD candidate

CONTACT

[email protected]

+905469417295

Sponsors and collaborators

Lead sponsor

Kocaeli City Hospital

Other Gov

Registry information

Official study title

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

Acronym: SCER-ICU

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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