An observational study in Pressure Injury, sponsored by hatice akaltun. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by hatice akaltun · Observational
This prospective observational mixed-methods study aims to develop and evaluate an explainable artificial intelligence model for staging pressure injuries using standardized clinical photographs and expert panel-labeled images from adult patients. The study will also explore nurses' views on the clinical acceptability and usability of the decision-support system through semi-structured interviews.
526 studies on the registry are indexed under Pressure Ulcer; 120 are open to participants now.
This study's planned enrollment of 415 is above the median of 155 across 98 observational studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →hatice akaltun is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adults aged 18 years or older with at least one pressure injury who are receiving care in the participating clinical units. Standardized clinical photographs and clinical data will be collected prospectively. In addition, approximately 10-15 nurses working in intensive care or surgical units and involved in pressure injury care will be invited to participate in individual semi-structured interviews. Patients and nurses will participate voluntarily after providing informed consent.
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For the qualitative component:
Exclusion Criteria:
Adult patients with pressure injuries whose standardized clinical photographs and clinical data will be collected prospectively. Pressure injuries will be independently staged by an expert panel, and the images will be used to develop and evaluate an explainable artificial intelligence model. No intervention will be administered.
Approximately 10-15 nurses working in intensive care and surgical units who provide pressure injury care will participate in individual semi-structured interviews. The interviews will explore their views on the clinical acceptability, usability, interpretability, and potential use of the explainable artificial intelligence decision-support system. No intervention will be administered.
Accuracy of the Explainable Artificial Intelligence Model in Pressure Injury Staging
The proportion of pressure injury images correctly staged by the explainable artificial intelligence model compared with the reference staging determined by the expert panel. Accuracy will be calculated as the number of correctly classified images divided by the total number of evaluable images.
Time frame: From completion of image collection through completion of data analysis, approximately 8 months
Nurses' Views on the Clinical Acceptability and Usability of the Explainable Artificial Intelligence Decision-Support System
Nurses' views will be explored through individual semi-structured interviews. The interviews will be analyzed using thematic analysis to identify perceptions of clinical acceptability, usability, interpretability, potential benefits, concerns, and barriers to using the system.
Time frame: From completion of nurse interviews through completion of qualitative data analysis, approximately 4 months
Plan to share: No — Individual participant-level data will not be shared because the dataset includes sensitive clinical photographs and interview data. Although the data will be de-identified, sharing may pose a risk of re-identification. Only aggregated and anonymized results will be reported.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 44 observational studies under Pressure Ulcer, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 141. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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