Prevention of Pressure Wound Development With Infrared Thermal Camera

January 12, 2024 updated by: Arzu İLÇE, Abant Izzet Baysal University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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 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.
Observational

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.
31

Contacts and Locations

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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

  • Turkey
    • Merkez
      • Bolu, Merkez, Turkey, 14000
        • Recruiting
        • İzzet Baysal Devlet Hastanesi
        • Contact:
        • Sub-Investigator:
          • Büşra Demir
        • Principal Investigator:
          • Arzu İlçe

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

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

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
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.
up to 10 days
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.
up to 10 days

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.
Abant Izzet Baysal University

Study record dates

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Study Major Dates

Study Start (Actual)

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.
January 3, 2024

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 3, 2024

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.
March 3, 2024

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).
January 3, 2024

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.
January 12, 2024

First Posted (Estimated)

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.
January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
January 23, 2024

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.
January 12, 2024

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.
January 1, 2024

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.
  • AIBÜ-SBF-BD-01
  • Büşra Demir (Other Identifier: AIBÜ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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