NCT07306143

Brief Summary

This study is a retrospective record review conducted among adult patients hospitalized in the intensive care unit of a tertiary hospital between October 10, 2020, and October 10, 2025. The aim of the study is to predict the risk of pressure injury development using demographic, clinical, laboratory, and nursing care-related variables by applying multiple data mining algorithms. No intervention, treatment, or patient contact will occur. All data will be extracted from existing electronic and paper-based medical records and will be fully anonymized prior to analysis. The study poses no risk to participants and will be conducted with approval from the institutional review board or ethics committee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

December 7, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

January 16, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

December 7, 2025

Last Update Submit

April 29, 2026

Conditions

Keywords

Pressure injury riskData miningMachine learningRetrospective studyRisk prediction

Outcome Measures

Primary Outcomes (1)

  • Prediction accuracy of pressure injury development

    The primary outcome is the predictive accuracy of data mining algorithms in identifying the risk of developing pressure injury among patients hospitalized in the intensive care unit (ICU). Accuracy metrics such as the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, precision, recall, and F1-score will be calculated using retrospective medical record data.

    10 October 2020 to 10 October 2025

Study Arms (1)

ICU Patient Cohort

Adult patients who will be hospitalized in the intensive care unit between October 10, 2020 and October 10, 2025. No interventions will be applied, and all data will be obtained from existing medical records.

Other: No intervention

Interventions

This is a retrospective observational study. No interventions will be applied. All data will be obtained from existing medical records.

ICU Patient Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients aged 18 years and older who were hospitalized in the intensive care unit (ICU) of a tertiary public hospital between October 10, 2020, and October 10, 2025 will be included in this retrospective observational study. The study population includes patients with a minimum ICU stay of 24 hours and complete, accessible electronic or paper-based medical records. Patients with missing or inconsistent medical record data or with a pressure injury diagnosed before or at the time of ICU admission will be excluded. All data will be collected retrospectively from existing medical records.

You may qualify if:

  • Patients hospitalized in the intensive care unit between October 10, 2020, and \* October 10, 2025
  • Adult patients aged 18 years and older
  • Length of intensive care unit stay of at least 24 hours
  • Availability of complete and accessible electronic or paper-based medical records

You may not qualify if:

  • Patients younger than 18 years
  • Intensive care unit stay shorter than 24 hours Incomplete, missing, or inconsistent electronic or paper-based medical records
  • Presence of a pressure injury diagnosed before or at the time of intensive care unit admission
  • Inability to extract pressure injury-related data from medical records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bolu Izzet Baysal State Hospital

Bolu, Bolu, 14100, Turkey (Türkiye)

Location

Bolu Izzet Baysal State Hospital

Merkez, Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Saadet Can Çiçek, Assoc. Prof., PhD

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 7, 2025

First Posted

December 29, 2025

Study Start

January 16, 2026

Primary Completion

April 1, 2026

Study Completion

April 29, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the study uses retrospective clinical records that contain sensitive personal health information. In accordance with institutional policies, ethical committee approval, and national data protection regulations (KVKK), IPD cannot be made publicly available. Only aggregated and de-identified results will be provided in publications.

Locations