EdemaSCER-ICUNCT07442344
Care Bundle for Prevention of Skin Complications and Edema in Restrained Patients
A study testing Evulation, Application of physical restraint material and Elevation in people with Edema and Dermatologic Complication, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edema, Dermatologic Complication, Physical Restraints
- What is being tested?
- Evulation, Application of physical restraint material and Elevation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Edema, Dermatologic Complication, Physical Restraints
- Being tested
- Evulation, Application of physical restraint material, Elevation, Hand massage
- Keywords
- physical restraint, edema, laseration, ulceration, intensive care unit, nursing, ecchymosis
- Medical subject headings
- Edema, Ulcer, Ecchymosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvulationOther
- 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 materialOther
- 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.
ElevationOther
- 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 massageOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Care Bundle | Experimental | 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. Receives: Other: Evulation; Other: Application of physical restraint material; Other: Elevation; Other: Hand massage |
| routine care | No intervention | Participants in this group will receive routine intensive care unit nursing care without implementation of the structured care bundle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
edema, ecchymosis, laceration, ulceration
The rates of edema, ecchymosis, laceration and ulceration developing in the restricted area in the days following physical restriction.
Measured: From the initiation of physical restraint to the 5th day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pinar Erman, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442344
- Sponsor's protocol ID
- 2025-203
- Acronym
- SCER-ICU
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will only be used for statistical analysis.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of the Effectiveness of a Dermatological Complications and Edema Prevention Care Package in the Physical Constraint Zone
- ClinicalTrials.gov ID
- NCT07442344
- Acronym / sponsor ID
- SCER-ICU / 2025-203
- Conditions
- Edema, Dermatologic Complication, Physical Restraints
- Keywords
- physical restraint, edema, laseration, ulceration, intensive care unit, nursing, ecchymosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care Bundle | Experimental | Other: Evulation, Other: Application of physical restraint material, Other: Elevation, Other: Hand massageParticipants 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. |
| routine care | No intervention | –Participants in this group will receive routine intensive care unit nursing care without implementation of the structured care bundle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • 18 years of age or older,
Key exclusion criteria (5 listed)
- In the physical restraint area;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evulation1. 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 | Care Bundle |
| Application of physical restraint material1. 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 | Care Bundle |
| Elevation1. 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 | Care Bundle |
| Hand massage1. 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. | Other | Care Bundle |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No. Patient data will only be used for statistical analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evulation, Application of physical restraint material and Elevation in people with Edema and Dermatologic Complication, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact pınar erman, PhD candidate (+905469417295, pinarugurag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
edema, ecchymosis, laceration, ulceration (time frame: From the initiation of physical restraint to the 5th day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.