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

NCT07853534 | Active Not Recruiting

• 2 other identifiers: E-13562490-050.01.04-635562126S980
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pressure Injury

Keywords

Artificial intelligence; evidence-based; intensive care; machine learning

Outcome Measures

Primary Outcomes (2)

• Change in Bates-Jensen Wound Assessment Tool Score

  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.

  Days 1, 3, 5, 7, 9, 11, and 13

• Change in Pressure Injury Surface Area

  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.

  Days 1, 3, 5, 7, 9, 11, and 13

Secondary Outcomes (1)

• Change in Braden Scale Score

  Days 1, 3, 5, 7, 9, 11, and 13

Study Arms (2)

Standard Clinical Care

ACTIVE COMPARATOR

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.

Other: Standard Clinical Care

Mobile Application-Supported Nursing Care

EXPERIMENTAL

Patients in this group will receive standard intensive care unit treatment and pressure ulcer care supported by the study's mobile application. Trained nurses will use this application to record assessments regarding pressure ulcer staging, evidence-based and stage-specific nursing care guidelines, and objective wound surface area measurements. Pressure ulcer outcomes will be measured using the same study assessment procedures as those used for the control group.

Device: Mobile Application for Pressure Injury Staging and Nursing Care Guidance

Interventions

Mobile Application for Pressure Injury Staging and Nursing Care Guidance DEVICE

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.

Mobile Application-Supported Nursing Care

Standard Clinical Care OTHER

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.

Standard Clinical Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ertugrul Sari: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Karadeniz Technical University Health Application and Research Center Farabi Hospital (Intensive Care Unit 3)

Trabzon, Trabzon, 61000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, PhD Student

Model Details: Two groups of patients with pressure injuries will be compared. The control group will receive standard clinical care. The intervention group will receive care supported by a mobile application that provides pressure injury staging and evidence-based, stage-specific nursing care guidance. Control group data will be collected before implementation of the mobile application, followed by intervention group data collection.

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 1, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE

Locations

TU (1)