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Active, not recruiting Not applicable

Machine Learning-Based Pressure Injury Staging and Nursing Care in Intensive Care

NCT07853534 · tracked via the Priya Life Science Turkey tracker
Sponsor
Ertugrul Sari
Phase
Not applicable
Started
2026-08-15
Last updated
2026-10-01

Condition(s) studied

Pressure Injury

Investigational drug(s) / intervention(s)

Mobile Application for Pressure Injury Staging and Nursing Care GuidanceStandard Clinical Care

Mobile Application for Pressure Injury Staging and Nursing Care Guidance: Specially trained intensive care nurses will use a mobile application during the assessment and care of patients with pressure injuries. The application employs a machine learning model to suggest the stage of the pressure injury based on an image of the wound and provides evidence-based, stage-specific nursing care guidance. It also enables objective measurement of the wound surface area. The application is intended for use alongside standard clinical care, and clinical decision-making will remain the responsibility of the healthcare team.

Standard Clinical Care: Patients in this arm will receive standard pressure injury care provided in the intensive care unit according to existing clinical practice. Nurses will assess and document the wounds without using the study's mobile application. Pressure injury outcomes will be measured using the same study assessment procedures as in the intervention arm.

Study summary

This study aims to develop a mobile nursing care system that uses machine learning to support pressure injury staging and to evaluate its effect on pressure injury healing in an intensive care unit. The system will provide stage-based care guidance and support wound monitoring.

The clinical evaluation will use a quasi-experimental, pretest-posttest design with a control group. A total of 70 patients with pressure injuries are planned to be included: 35 in the intervention group and 35 in the control group. Data will be collected using a patient information and monitoring form, the Braden Scale, and the Bates-Jensen Wound Assessment Tool. Changes in wound condition and healing will be compared between the groups.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Aged 18 to 65 years. * Diagnosed with a pressure injury. * Hemodynamically stable, as assessed by the treating clinician. * Remained in the intensive care unit for at least 48 hours after identification of the pressure injury. * The patient or their legal representative provides verbal and written informed consent after receiving information about the study. Exclusion Criteria: * Intensive care unit stay of less than 48 hours after identification of the pressure injury. * The wound cannot be photographed because of extensive infection or necrotic tissue in the wound area. * The patient or their legal representative does not consent to participation.

Primary outcome measure(s)

  • Change in Bates-Jensen Wound Assessment Tool Score — Days 1, 3, 5, 7, 9, 11, and 13
    Pressure injury status will be assessed using the Bates-Jensen Wound Assessment Tool. Scores range from 13 to 65, with lower scores indicating better wound status. Change from Day 1 to Day 13 and scores at each assessment will be compared between groups.
  • Change in Pressure Injury Surface Area — Days 1, 3, 5, 7, 9, 11, and 13
    Pressure injury surface area will be recorded in cm² on Days 1, 3, 5, 7, 9, 11, and 13. In the intervention group, the mobile application will calculate the wound area. Changes from Day 1 to Day 13 and trends over time will be compared between groups. A decrease in surface area will indicate wound healing.

Trial sites (1)

FacilityCityRegionStatus
Karadeniz Technical University Health Application and Research Center Farabi Hospital (Intensive Care Unit 3) Trabzon Trabzon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07853534 on ClinicalTrials.gov ↗ ← All trials in Turkey