NCT06219954

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

January 3, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

January 3, 2024

Last Update Submit

January 12, 2024

Conditions

Keywords

pressure woundbraden scaleinfrared thermographythermal imageinfrared thermal camera

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    up to 10 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzzet Baysal Devlet Hastanesi

Bolu, Merkez, 14000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 23, 2024

Study Start

January 3, 2024

Primary Completion

March 3, 2024

Study Completion

March 3, 2024

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations