The Study Focuses on Skin Assessment and PI Staging in ICU PatientsIT-PIPNCT07318571
AI-Assisted Skin Assessment for Pressure Injury Prevention in Critical Care Nurses
A study testing ChatGPT Skin Assessment in people with The Study Focuses on Skin Assessment and PI Staging in ICU Patients, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to learn whether an artificial intelligence (AI)-assisted skin assessment tool can improve the accuracy of pressure-injury staging in critical-care nurses. The study also aims to understand whether the AI tool increases nurses' knowledge and confidence in performing skin assessments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Study Focuses on Skin Assessment and PI Staging in ICU Patients
- What is being tested?
- ChatGPT Skin Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 24 Nov 2025to 16 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nurses working within the organisation for at least 6 months
- Nurses involved in direct patient care for over 50% of their work time.
- Skin assessments and staging for patients at risk for developing pressure injuries (Using the Braden Scoring system).
- Adult Patients (18 years and older)
- Patients who are currently admitted to the ICU and are receiving critical care treatment.
- No current severe skin conditions patients without active severe dermatological conditions (e.g., large open wounds, severe rashes) that would interfere with the AI-based skin assessment process.
Who cannot join
- Nurses working within the organization for less than 6 months
- Nurses involved in direct patient care for less than 50% of their work time
- End-of-Life Care or Terminal Illness- patients receiving end-of-life care or those with a terminal diagnosis, where the prevention of pressure injuries may not be a priority and where participation in the study may not align with their care goals.
- Severe or active dermatological conditions- patients with active skin conditions such as severe rashes, burns, or other dermatological issues that could interfere with accurate skin assessments by AI or confound the study results.
- Recent Skin Grafts or Advanced Wound Care- patients who have recently undergone skin grafts or those receiving complex wound care treatments that are outside the scope of typical pressure injury prevention practices.
- Inability to Maintain Required Positioning for Skin Assessment- patients who are physically unable to remain in the necessary position for the skin assessments, either due to severe mobility restrictions or critical medical conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Faisal Specialist Hospital and Research Center- Jeddah
Jeddah, Mecca Region, 21423
Abeer Omer, MBBS, +966114423657/+966503284853, aomer@kfshrc.edu.sa
Aziz Ashraf Afshan, MBCHB, +966554965750, aali01@kfshrc.edu.sa
About this study
Official title: A Randomized Controlled Trial on the Application of Artificial Intelligence (AI) in Skin Assessment for Pressure Injury Prevention and Staging by Critical Care Nurses
The goal of this clinical trial is to learn whether an artificial intelligence (AI)-assisted skin assessment tool can improve the accuracy of pressure-injury staging in critical-care nurses. The study also aims to understand whether the AI tool increases nurses' knowledge and confidence in performing skin assessments. The main questions it aims to answer are:
Does AI-assisted assessment improve the accuracy of pressure-injury staging compared with standard visual assessment?
Read more
Does the use of AI improve nurses' knowledge and confidence related to skin assessment and pressure-injury staging?
Researchers will compare nurses who use an AI-assisted mobile application with nurses who perform standard manual assessments to see whether the AI tool improves staging accuracy and supports early identification of pressure injuries.
Participants will:
Complete brief questionnaires about their knowledge and confidence before and after training
Perform skin assessments on their assigned ICU patients using either standard methods or the AI tool.
Have their assessments compared with those of a blinded wound-care specialist, who will determine the most accurate staging
Read the detailed description
Pressure injuries remain a significant and largely preventable complication among critically ill patients, with ICU populations at particularly high risk due to immobility, hemodynamic instability, and complex medical needs. At KFSHRC-Jeddah, more than half of all hospital-acquired pressure injuries reported in 2024 occurred in critical-care settings, underscoring ongoing challenges in early detection and consistent staging. Although the organization follows evidence-based practices and uses tools such as the Braden Scale and NPIAP staging guidelines, variability in nurses' knowledge, skill, and confidence continues to influence prevention quality and accuracy of assessment.
Traditional skin assessment relies primarily on visual inspection and clinical judgement, which can lead to inconsistent interpretation of early tissue changes, particularly in darker skin tones, deep tissue injuries, and moisture-associated skin damage. These limitations highlight the need for innovative approaches that support more consistent and objective staging.
Artificial intelligence (AI)-assisted image recognition has emerged as a potentially valuable adjunct to standard nursing assessment. By analyzing skin characteristics such as color, texture, and contour, AI tools may assist nurses in identifying early-stage changes and provide decision support aligned with NPIAP criteria. Integrating AI into routine practice has the potential to enhance early detection, improve staging accuracy, and reduce practice variation.
This randomized controlled trial evaluates the use of an AI-assisted mobile application compared with standard manual skin assessment performed by critical-care nurses. The intervention uses an image-recognition tool that analyzes standardized photographs of high-risk skin areas and provides staging recommendations based on NPIAP definitions. Nurses in the control group will continue performing traditional visual and palpation-based assessments according to existing hospital protocols.
All participating nurses will receive pre-intervention education on pressure injury prevention, comprehensive skin assessment, and NPIAP staging to establish a consistent baseline. The intervention group will undergo additional training on standardized image capture to ensure appropriate lighting, distance, and positioning. A blinded wound-care specialist will independently review all assessments and images; this external review serves as the reference standard for evaluating accuracy and inter-rater reliability.
In addition to examining staging accuracy, the study will assess changes in nurses' knowledge and confidence before and after the intervention using validated instruments. It will also explore the feasibility and acceptability of integrating AI into ICU workflows. The findings are expected to inform how AI technology can support nursing practice, enhance clinical decision-making, and help reduce the incidence of hospital-acquired pressure injuries in critical-care environments.
- Being tested
- ChatGPT Skin Assessment
- Keywords
- Artificial intelligence, critical care, intensive care, nurses, Pressure injuries
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatGPT Skin AssessmentOther
ChatGPT Skin Assessment
| Study group | Role | What they receive |
|---|---|---|
| Standard Assessment | No intervention | Standard assessment |
| ChatGPT-Assisted Skin Assessmen | Other | Nurses will use ChatGPT-based AI support to assist in skin assessment and staging. Receives: Other: ChatGPT Skin Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between Nurse and Expert Skin Assessment and Pressure Injury Staging Using NPIAP Criteria
The primary outcome explicitly measures agreement between nurse-assigned and expert-assigned pressure injury stages using the National Pressure Injury Advisory Panel (NPIAP) staging criteria, rather than stating a study objective. Agreement will be quantified using Cohen's Kappa statistic, and accuracy will be summarized as the percentage of nurse-assigned stages that exactly match expert-assigned stages. Agreement analyses will be conducted separately for manual nurse assessments and AI-assisted nurse assessments, allowing clear and reportable comparison between study groups.
Agreement outcomes will be summarized across individual assessment domains, including erythema, discoloration, edema, temperature, and overall pressure injury staging, using quantitative agreement metrics. The primary outcome will be assessed from Day 1 through 6 months.
Measured: Day 1 through 6 months
Secondary outcomes (2)
Knowledge- Change From Baseline in Nurse Knowledge Score on the Pressure Ulcer Prevention Knowledge Assessment Instrument (PUPKAI)
Nurse knowledge related to pressure injury prevention and staging will be measured using the Pressure Ulcer Prevention Knowledge Assessment Instrument (PUPKAI), a validated 26-item multiple-choice questionnaire. Each correct response will be scored as one point, and item scores will be summed to generate a total knowledge score ranging from 0 to 26, with higher scores indicating greater knowledge.
Total PUPKAI scores will be calculated at two prespecified time points: Day 1 (baseline, prior to the intervention) and Day 1 (immediately post-intervention). The outcome will be reported as change from baseline in total PUPKAI score, calculated as the post-intervention score minus the baseline score.
For statistical analysis, descriptive statistics will be used to summarize baseline and post-intervention scores. Within-group changes in PUPKAI scores will be analyzed using paired statistical tests (paired t-test or Wilcoxon signed-rank test, depending on data distribution).
Measured: Day 1 (Baseline) and Day 1 (Immediately Post-intervention)
Change From Baseline in Nurse Confidence Score on the Skin Assessment Confidence Scale (SACS)
Nurse confidence in skin assessment and pressure injury staging will be measured using the Skin Assessment Confidence Scale (SACS), a 10-item Likert-scale instrument. Each item is scored on a 5-point scale, and item scores are summed to generate a total confidence score ranging from 10 to 50, with higher scores indicating greater confidence in performing skin assessments and applying pressure injury staging criteria.
Total SACS scores will be calculated at two prespecified time points: Day 1 (baseline, prior to the intervention) and Day 1 (immediately post-intervention). The outcome will be reported as change from baseline in total SACS score, calculated as the post-intervention score minus the baseline score.
For statistical analysis, descriptive statistics will be used to summarize baseline and post-intervention confidence scores. Within-group changes in SACS scores will be analyzed using paired statistical tests (paired t-test or Wilcoxon signed-rank test, depending on data distr
Measured: Day 1 (Baseline) and Day 1 (Immediately Post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start24 Nov 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion16 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Study Focuses on Skin Assessment and PI Staging in ICU PatientsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer De Beer, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318571
- Sponsor's protocol ID
- RAC 2251201
- Other IDs
- Research Ethics Committee
- Acronym
- IT-PIP
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly because the dataset includes clinical images and sensitive nursing performance data collected within a single hospital site. These data could potentially identify participants, and institutional policy at King Faisal Specialist Hospital and Research Centre restricts the external sharing of raw clinical data. Aggregated and de-identified summary results will be available upon reasonable request following publication of study findings.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Application of Artificial Intelligence (AI) in Skin Assessment for Pressure Injury Prevention and Staging by Critical Care Nurses
- ClinicalTrials.gov ID
- NCT07318571
- Acronym / sponsor ID
- IT-PIP / RAC 2251201
- Keywords
- Artificial intelligence, critical care, intensive care, nurses, Pressure injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 16 May 2026 (estimated)
- First posted
- 6 Jan 2026 (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.
The goal of this clinical trial is to learn whether an artificial intelligence (AI)-assisted skin assessment tool can improve the accuracy of pressure-injury staging in critical-care nurses. The study also aims to understand whether the AI tool increases nurses' knowledge and confidence in performing skin assessments. The main questions it aims to answer are:
Does AI-assisted assessment improve the accuracy of pressure-injury staging compared with standard visual assessment?
Does the use of AI improve nurses' knowledge and confidence related to skin assessment and pressure-injury staging?
Researchers will compare nurses who use an AI-assisted mobile application with nurses who perform standard manual assessments to see whether the AI tool improves staging accuracy and supports early identification of pressure injuries.
Participants will:
Complete brief questionnaires about their knowledge and confidence before and after training
Perform skin assessments on their assigned ICU patients using either standard methods or the AI tool.
Have their assessments compared with those of a blinded wound-care specialist, who will determine the most accurate staging
Detailed description
Pressure injuries remain a significant and largely preventable complication among critically ill patients, with ICU populations at particularly high risk due to immobility, hemodynamic instability, and complex medical needs. At KFSHRC-Jeddah, more than half of all hospital-acquired pressure injuries reported in 2024 occurred in critical-care settings, underscoring ongoing challenges in early detection and consistent staging. Although the organization follows evidence-based practices and uses tools such as the Braden Scale and NPIAP staging guidelines, variability in nurses' knowledge, skill, and confidence continues to influence prevention quality and accuracy of assessment.
Traditional skin assessment relies primarily on visual inspection and clinical judgement, which can lead to inconsistent interpretation of early tissue changes, particularly in darker skin tones, deep tissue injuries, and moisture-associated skin damage. These limitations highlight the need for innovative approaches that support more consistent and objective staging.
Artificial intelligence (AI)-assisted image recognition has emerged as a potentially valuable adjunct to standard nursing assessment. By analyzing skin characteristics such as color, texture, and contour, AI tools may assist nurses in identifying early-stage changes and provide decision support aligned with NPIAP criteria. Integrating AI into routine practice has the potential to enhance early detection, improve staging accuracy, and reduce practice variation.
This randomized controlled trial evaluates the use of an AI-assisted mobile application compared with standard manual skin assessment performed by critical-care nurses. The intervention uses an image-recognition tool that analyzes standardized photographs of high-risk skin areas and provides staging recommendations based on NPIAP definitions. Nurses in the control group will continue performing traditional visual and palpation-based assessments according to existing hospital protocols.
All participating nurses will receive pre-intervention education on pressure injury prevention, comprehensive skin assessment, and NPIAP staging to establish a consistent baseline. The intervention group will undergo additional training on standardized image capture to ensure appropriate lighting, distance, and positioning. A blinded wound-care specialist will independently review all assessments and images; this external review serves as the reference standard for evaluating accuracy and inter-rater reliability.
In addition to examining staging accuracy, the study will assess changes in nurses' knowledge and confidence before and after the intervention using validated instruments. It will also explore the feasibility and acceptability of integrating AI into ICU workflows. The findings are expected to inform how AI technology can support nursing practice, enhance clinical decision-making, and help reduce the incidence of hospital-acquired pressure injuries in critical-care environments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Assessment | No intervention | –Standard assessment |
| ChatGPT-Assisted Skin Assessmen | Other | Other: ChatGPT Skin AssessmentNurses will use ChatGPT-based AI support to assist in skin assessment and staging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Nurses working within the organisation for at least 6 months
- Nurses involved in direct patient care for over 50% of their work time.
- Skin assessments and staging for patients at risk for developing pressure injuries (Using the Braden Scoring system).
- Adult Patients (18 years and older)
- Patients who are currently admitted to the ICU and are receiving critical care treatment.
Key exclusion criteria (6 listed)
- Nurses working within the organization for less than 6 months
- Nurses involved in direct patient care for less than 50% of their work time
- End-of-Life Care or Terminal Illness- patients receiving end-of-life care or those with a terminal diagnosis, where the prevention of pressure injuries may not be a priority and where participation in the study may not align with their care goals.
- Severe or active dermatological conditions- patients with active skin conditions such as severe rashes, burns, or other dermatological issues that could interfere with accurate skin assessments by AI or confound the study results.
- Recent Skin Grafts or Advanced Wound Care- patients who have recently undergone skin grafts or those receiving complex wound care treatments that are outside the scope of typical pressure injury prevention practices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChatGPT Skin AssessmentChatGPT Skin Assessment | Other | ChatGPT-Assisted Skin Assessmen |
Primary outcome
Agreement Between Nurse and Expert Skin Assessment and Pressure Injury Staging Using NPIAP Criteria
Time frame: Day 1 through 6 months
The primary outcome explicitly measures agreement between nurse-assigned and expert-assigned pressure injury stages using the National Pressure Injury Advisory Panel (NPIAP) staging criteria, rather than stating a study objective. Agreement will be quantified using Cohen's Kappa statistic, and accuracy will be summarized as the percentage of nurse-assigned stages that exactly match expert-assigned stages. Agreement analyses will be conducted separately for manual nurse assessments and AI-assisted nurse assessments, allowing clear and reportable comparison between study groups. Agreement outcomes will be summarized across individual assessment domains, including erythema, discoloration, edema, temperature, and overall pressure injury staging, using quantitative agreement metrics. The primary outcome will be assessed from Day 1 through 6 months.
2 secondary outcomes
Knowledge- Change From Baseline in Nurse Knowledge Score on the Pressure Ulcer Prevention Knowledge Assessment Instrument (PUPKAI)
Time frame: Day 1 (Baseline) and Day 1 (Immediately Post-intervention)
Change From Baseline in Nurse Confidence Score on the Skin Assessment Confidence Scale (SACS)
Time frame: Day 1 (Baseline) and Day 1 (Immediately Post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly because the dataset includes clinical images and sensitive nursing performance data collected within a single hospital site. These data could potentially identify participants, and institutional policy at King Faisal Specialist Hospital and Research Centre restricts the external sharing of raw clinical data. Aggregated and de-identified summary results will be available upon reasonable request following publication of study findings.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChatGPT Skin Assessment in people with The Study Focuses on Skin Assessment and PI Staging in ICU Patients, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. 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 Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Jennifer De Beer, PhD (+966559232671, debeerj@kfshrc.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between Nurse and Expert Skin Assessment and Pressure Injury Staging Using NPIAP Criteria (time frame: Day 1 through 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.