Pressure UlcerNCT06219954
Prevention of Pressure Wound Development With Infrared Thermal Camera
An observational study of Pressure Ulcer, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Pressure wound (PW) is generally defined as localized damage to the skin and subcutaneous soft tissue on a bone protrusion or caused by medical devices. Although it is a preventable complication and one of the quality indicators for healthcare institutions, the prevalence of PW is high.Up to 95% of pressure wounds are… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2024to 3 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population of the research will consist of patients who meet the inclusion criteria in the 3-level intensive care clinics of Bolu İzzet Baysal State Hospital.
Who may be able to join
- Patients receiving treatment in intensive care
- Patients aged 18 and over
- Patients with Braden score less than 18 points
- Patients who are not transferred from another intensive care unit
- Patients who can tolerate supine, prone and right/left lateral position changes and turns
Who cannot join
- Patients with previous acute or chronic skin damage or burns in the observation area
- Patients with Braden score over 18 points
- Patients with full-thickness pressure sores
- Patients with protective dressings on the skin or undergoing hot and cold therapy that may affect the skin
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İzzet Baysal Devlet Hastanesi
Bolu, Merkez, 14000
Büşra Demir, +90 5309128224, demr.busra04@gmail.com
Büşra Demir
About this study
Pressure wound (PW) is generally defined as localized damage to the skin and subcutaneous soft tissue on a bone protrusion or caused by medical devices. Although it is a preventable complication and one of the quality indicators for healthcare institutions, the prevalence of PW is high.Up to 95% of pressure wounds are preventable, but pressure wounds are only detected when sores become visible. Infrared thermography is used in the physiological and anatomical assessment of skin and subcutaneous tissue abnormalities and in detecting pressure injuries by measuring temperature changes caused by circulatory problems.The aim of the researchers is to compare the development of PW in patients admitted to intensive care by imaging the skin temperature in pressure areas using the traditional method and an infrared camera.
Read the detailed description
Pressure wound (PW); It is localized skin and/or subcutaneous tissue damage, usually occurring on bony prominences, caused by pressure alone or by a combination of shear and pressure.PW is an important source of infection that increases the mortality and morbidity rates of patients, causes an increase in health care costs, causes patients to feel more pain and prolongs the duration of hospital stay, negatively affects the quality of life and causes physical, social and psychological problems, and is an important source of infection, septicemia, It is a global health problem that causes complications such as osteomyelitis and has begun to be accepted as a quality indicator of nursing care. PW, although the risk factors that cause pressure sores are known, there are evidence-level guidelines for preventing pressure ulcers, treatment methods are known, and technological and scientific developments are made, it still appears as a current and serious health problem today.Considering the results of international studies, it has been shown that the prevalence of pressure wounds varies between 7.2-11.6%, the incidence rates vary between 1.9-54.8%, and if precautions are not taken, pressure sores may develop in approximately 87% of patients hospitalized for a long time.Up to 95% of pressure wounds are preventable, but pressure wounds are difficult to detect at an early stage as they can only be detected when the sores become visible.This is because the metabolic demand of the skin is much lower than that of the muscles, the muscles need more oxygen and are more susceptible to ischemia than the skin and surrounding fatty tissue. In this case, the lesions develop in the deep muscle tissue and gradually reach the skin and become visible.Studies have shown that inflammatory and apoptotic/necrotic changes in the epidermal and dermal layers of the skin occur 3-10 days before surface changes.Therefore, a pressure wound in the early stages is difficult to distinguish visually from healthy tissue that responds normally to pressure-inducing factors. Studies have reported that a period of 1 to 7 days must pass from the moment an injury occurs to the tissue for it to appear visually.Risk factors leading to pressure wounds; It can be detected in advance using traditional methods such as visual assessment and the Braden Risk Scale, but these methods are affected by skin color and only 20-40% of pressure wounds can be detected.Infrared thermal camera is a temperature measurement technique that visualizes body thermal energy produced by cellular metabolism and blood circulation in the human body.In body parts where blood flow is impaired, temperature losses occur due to the slowdown of cellular metabolism. Accordingly, when blood flow in the body increases or decreases, there is an increase or decrease in thermal energy measured by an infrared thermal camera. Thus, the infrared thermal camera can be used for physiological and anatomical evaluation of abnormalities in the skin and subcutaneous tissue. The aim of the researchers is to disrupt the basic wound change by imaging the skin temperature under pressure conditions admitted to intensive care with the traditional method and a split camera. New evaluation tools are needed to detect the distribution and pressure sores in the early stages.
- Conditions
- Pressure Ulcer
- Keywords
- pressure wound, braden scale, infrared thermography, thermal image, infrared thermal camera
- Medical subject headings
- Pressure Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
Braden Risk Assessment Scale
The Braden Scale has 6 subdomains. Sensory perception, mobility, moisture, nutrition and activity from 1 to 4; It is scored as 1 being the worst and 4 being the best. Friction is evaluated on 3 different scores, 1 being the worst and 3 being the best. A score between 6-23 is obtained by calculating a total of 6 different categories.
Measured: up to 10 days
Body/Pressure Zones Temperature Form Measured by Infrared Thermography
Measurements will be made of the reference region centered on T1, one of the regions where the risk of pressure injury is considered to be high. In addition, in order to eliminate the effects of endogenous and/or exogenous factors, the distal part, which is at least 10-15 cm away from the areas to be measured, that is, the T2-centered reference region, which is considered the least risky, will be measured with infrared thermography. The temperature difference (ΔT) between these two regions will be calculated (ΔT = T1-T2). When applying the infrared thermal camera to the patient, measurements will be made from a distance of 30 cm at a 90-degree angle after the curtains in the area where the patient lies, ensuring privacy, and the bed borders are removed and safety precautions are taken to prevent the patient from falling.
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start3 Jan 2024
- Primary completion3 Mar 2024 (estimated)
- Study completion3 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu İLÇE, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219954
- Sponsor's protocol ID
- AIBÜ-SBF-BD-01
- Other IDs
- Büşra Demir
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demir B, Ilce AO. The Use of Infrared Thermal Imaging Camera to Prevent the Development of Pressure Injuries. Nurs Crit Care. 2026 Mar;31(2):e70405. doi: 10.1111/nicc.70405.
PubMed 41808466
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Pressure Wound Development With Infrared Thermal Camera
- ClinicalTrials.gov ID
- NCT06219954
- Acronym / sponsor ID
- AIBÜ-SBF-BD-01
- Conditions
- Pressure Ulcer
- Keywords
- pressure wound, braden scale, infrared thermography, thermal image, infrared thermal camera
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 3 Mar 2024 (estimated)
- Study completion
- 3 Mar 2024 (estimated)
- First posted
- 23 Jan 2024 (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.
Pressure wound (PW) is generally defined as localized damage to the skin and subcutaneous soft tissue on a bone protrusion or caused by medical devices. Although it is a preventable complication and one of the quality indicators for healthcare institutions, the prevalence of PW is high.Up to 95% of pressure wounds are preventable, but pressure wounds are only detected when sores become visible. Infrared thermography is used in the physiological and anatomical assessment of skin and subcutaneous tissue abnormalities and in detecting pressure injuries by measuring temperature changes caused by circulatory problems.The aim of the researchers is to compare the development of PW in patients admitted to intensive care by imaging the skin temperature in pressure areas using the traditional method and an infrared camera.
Detailed description
Pressure wound (PW); It is localized skin and/or subcutaneous tissue damage, usually occurring on bony prominences, caused by pressure alone or by a combination of shear and pressure.PW is an important source of infection that increases the mortality and morbidity rates of patients, causes an increase in health care costs, causes patients to feel more pain and prolongs the duration of hospital stay, negatively affects the quality of life and causes physical, social and psychological problems, and is an important source of infection, septicemia, It is a global health problem that causes complications such as osteomyelitis and has begun to be accepted as a quality indicator of nursing care. PW, although the risk factors that cause pressure sores are known, there are evidence-level guidelines for preventing pressure ulcers, treatment methods are known, and technological and scientific developments are made, it still appears as a current and serious health problem today.Considering the results of international studies, it has been shown that the prevalence of pressure wounds varies between 7.2-11.6%, the incidence rates vary between 1.9-54.8%, and if precautions are not taken, pressure sores may develop in approximately 87% of patients hospitalized for a long time.Up to 95% of pressure wounds are preventable, but pressure wounds are difficult to detect at an early stage as they can only be detected when the sores become visible.This is because the metabolic demand of the skin is much lower than that of the muscles, the muscles need more oxygen and are more susceptible to ischemia than the skin and surrounding fatty tissue. In this case, the lesions develop in the deep muscle tissue and gradually reach the skin and become visible.Studies have shown that inflammatory and apoptotic/necrotic changes in the epidermal and dermal layers of the skin occur 3-10 days before surface changes.Therefore, a pressure wound in the early stages is difficult to distinguish visually from healthy tissue that responds normally to pressure-inducing factors. Studies have reported that a period of 1 to 7 days must pass from the moment an injury occurs to the tissue for it to appear visually.Risk factors leading to pressure wounds; It can be detected in advance using traditional methods such as visual assessment and the Braden Risk Scale, but these methods are affected by skin color and only 20-40% of pressure wounds can be detected.Infrared thermal camera is a temperature measurement technique that visualizes body thermal energy produced by cellular metabolism and blood circulation in the human body.In body parts where blood flow is impaired, temperature losses occur due to the slowdown of cellular metabolism. Accordingly, when blood flow in the body increases or decreases, there is an increase or decrease in thermal energy measured by an infrared thermal camera. Thus, the infrared thermal camera can be used for physiological and anatomical evaluation of abnormalities in the skin and subcutaneous tissue. The aim of the researchers is to disrupt the basic wound change by imaging the skin temperature under pressure conditions admitted to intensive care with the traditional method and a split camera. New evaluation tools are needed to detect the distribution and pressure sores in the early stages.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the research will consist of patients who meet the inclusion criteria in the 3-level intensive care clinics of Bolu İzzet Baysal State Hospital.
Key inclusion criteria (5 listed)
- Patients receiving treatment in intensive care
- Patients aged 18 and over
- Patients with Braden score less than 18 points
- Patients who are not transferred from another intensive care unit
- Patients who can tolerate supine, prone and right/left lateral position changes and turns
Key exclusion criteria (4 listed)
- Patients with previous acute or chronic skin damage or burns in the observation area
- Patients with Braden score over 18 points
- Patients with full-thickness pressure sores
- Patients with protective dressings on the skin or undergoing hot and cold therapy that may affect the skin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Braden Risk Assessment Scale
Time frame: up to 10 days
The Braden Scale has 6 subdomains. Sensory perception, mobility, moisture, nutrition and activity from 1 to 4; It is scored as 1 being the worst and 4 being the best. Friction is evaluated on 3 different scores, 1 being the worst and 3 being the best. A score between 6-23 is obtained by calculating a total of 6 different categories.
Body/Pressure Zones Temperature Form Measured by Infrared Thermography
Time frame: up to 10 days
Measurements will be made of the reference region centered on T1, one of the regions where the risk of pressure injury is considered to be high. In addition, in order to eliminate the effects of endogenous and/or exogenous factors, the distal part, which is at least 10-15 cm away from the areas to be measured, that is, the T2-centered reference region, which is considered the least risky, will be measured with infrared thermography. The temperature difference (ΔT) between these two regions will be calculated (ΔT = T1-T2). When applying the infrared thermal camera to the patient, measurements will be made from a distance of 30 cm at a 90-degree angle after the curtains in the area where the patient lies, ensuring privacy, and the bed borders are removed and safety precautions are taken to prevent the patient from falling.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 41808466Demir B, Ilce AO. The Use of Infrared Thermal Imaging Camera to Prevent the Development of Pressure Injuries. Nurs Crit Care. 2026 Mar;31(2):e70405. doi: 10.1111/nicc.70405.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer, run by Abant Izzet Baysal University 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arzu İlçe (+90 374 253 45 20 ext. 6187, ilce_a@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Braden Risk Assessment Scale (time frame: up to 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06219954, which also lists 1 linked publication.
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 23 Jan 2024.