Combined Molecular and Mechanistic Methods for Detection of Pressure Ulcers
NCT Number: NCT06468306
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Pressure Ulcer|Inflammatory Response
Interventions: PROCEDURE: non-invasive ventilation teraphy, NIV
Sponsor: Linkoeping University
Collaborators: Region Östergötland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2027-12-30
Locations: Linköping University, Linköping, 58183, Sweden

Summary:
This project aims to develop a novel method for identifying early tissue damage related to pressure ulcer (PU) development in vulnerable patients by measuring biomarkers of inflammation on the skin surface. PUs are common and costly injuries that result from prolonged pressure on the skin. Current methods to assess PU risk are unreliable, and the mechanisms of PU development are not well understood. This project contributes to new knowledge of PU etiology as well as the individual variability at a molecular level combined with new knowledge about nursing actions and clinical factors linked to PU progression and outcomes of prevention. The project will use non-invasive techniques and model-based analysis to identify specific biomolecules that reflect individual susceptibility to pressure exposure in different PU risk scenarios.

Primary Outcome Measures: CTACK, inflammatory biomarker, 2 minutes|ENA-78, inflammatory biomarker, 2 minutes|Eotaxin, inflammatory biomarker, 2 minutes|Eotaxin-2, inflammatory biomarker, 2 minutes|Eotaxin-3, inflammatory biomarker, 2 minutes|EPO, inflammatory biomarker, 2 minutes|FLT3L, inflammatory biomarker, 2 minutes|Fractalkine, inflammatory biomarker, 2 minutes|G-CSF, inflammatory biomarker, 2 minutes|GM-CSF, inflammatory biomarker, 2 minutes|GRO-alpha, inflammatory biomarker, 2 minutes|I-309, inflammatory biomarker, 2 minutes|IFN-α2a, inflammatory biomarker, 2 minutes|IFN-β, inflammatory biomarker, 2 minutes|IFN-γ, inflammatory biomarker, 2 minutes|IL-10, inflammatory biomarker, 2 minutes|IL-12/IL-23p40, inflammatory biomarker, 2 minutes|IL-12p70, inflammatory biomarker, 2 minutes|IL-13, inflammatory biomarker, 2 minutes|IL-15, inflammatory biomarker, 2 minutes|IL-16, inflammatory biomarker, 2 minutes|IL-17A, inflammatory biomarker, 2 minutes|IL-17A/F, inflammatory biomarker, 2 minutes|IL-17B, inflammatory biomarker, 2 minutes|IL-17C, inflammatory biomarker, 2 minutes|IL-17D, inflammatory biomarker, 2 minutes|IL-17E/IL-25, inflammatory biomarker, 2 minutes|IL-17F, inflammatory biomarker, 2 minutes|IL-18, inflammatory biomarker, 2 minutes|IL-1RA, inflammatory biomarker, 2 minutes|IL-1α, inflammatory biomarker, 2 minutes|IL-1β, inflammatory biomarker, 2 minutes|IL-2, inflammatory biomarker, 2 minutes|IL-21, inflammatory biomarker, 2 minutes|IL-22, inflammatory biomarker, 2 minutes|IL-23, inflammatory biomarker, 2 minutes|IL-27, inflammatory biomarker, 2 minutes|IL-29/IFN-L1, inflammatory biomarker, 2 minutes|IL-2Ra, inflammatory biomarker, 2 minutes|IL-3, inflammatory biomarker, 2 minutes|IL-31, inflammatory biomarker, 2 minutes|IL-33, inflammatory biomarker, 2 minutes|IL-4, inflammatory biomarker, 2 minutes|IL-5, inflammatory biomarker, 2 minutes|IL-6, inflammatory biomarker, 2 minutes|IL-7, inflammatory biomarker, 2 minutes|IL-8, inflammatory biomarker, 2 minutes|IL-9, inflammatory biomarker, 2 minutes|IP-10, inflammatory biomarker, 2 minutes|I-TAC, inflammatory biomarker, 2 minutes|MCP-1, inflammatory biomarker, 2 minutes|MCP-2, inflammatory biomarker, 2 minutes|MCP-3, inflammatory biomarker, 2 minutes|MCP-4, inflammatory biomarker, 2 minutes|M-CSF, inflammatory biomarker, 2 minutes|MDC, inflammatory biomarker, 2 minutes|MIF, inflammatory biomarker, 2 minutes|MIP-1α, inflammatory biomarker, 2 minutes|MIP-1β, inflammatory biomarker, 2 minutes|MIP-3α, inflammatory biomarker, 2 minutes|MIP-3β, inflammatory biomarker, 2 minutes|MIP-5, inflammatory biomarker, 2 minutes|SDF-1alpha, inflammatory biomarker, 2 minutes|TARC, inflammatory biomarker, 2 minutes|TNF-α, inflammatory biomarker, 2 minutes|TNF-β, inflammatory biomarker, 2 minutes|TPO, inflammatory biomarker, 2 minutes|TRAIL, inflammatory biomarker, 2 minutes|TSLP, inflammatory biomarker, 2 minutes|VEGF-A, inflammatory biomarker, 2 minutes|YKL-40, inflammatory biomarker, 2 minutes