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Combined Molecular and Mechanistic Methods for Detection of Pressure Ulcers

Combined Molecular and Mechanistic Methods for Early Detection and Individual Prevention of Pressure Ulcer Formation in Vulnerable Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06468306
Enrollment
150
Registered
2024-06-21
Start date
2024-08-01
Completion date
2027-12-30
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Response, Pressure Ulcer

Keywords

Pressure Ulcer, nursing, prevention

Brief 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.

Detailed description

Purpose and aims A pressure ulcer (PU) is a localized injury to the skin and/or underlying tissue and develop from prolonged pressure on the skin. Such injuries are common in the healthcare setting, especially among vulnerable elderly. PUs greatly decrease the quality of life of individuals and are costly for the healthcare system. As many as 14% of the inpatients suffered from PUs in the Swedish country's municipalities and regions during 2022. The origin and timing of events leading to PUs are not fully understood, and current methods to assess the risk for an individual to develop a PU, are unreliable. Therefore, there is an urgent need to develop more objective, sensitive and specific methods for identifying early signs of tissue damage before they come visible and thus avoid development of PUs. The investigators have previously identified a preliminary set of molecular biomarkers (cytokines and proteins), sampled non-invasively in the sebum, that reflects the inflammatory process under-pinning PU etiology and, possibly, individual susceptibility to pressure exposure. Therefore, it is hypothesize that non-invasive measurements of specific biomolecules on the skin surface, together with model-based analysis, can be used for individualized PU prediction. Accordingly, the purpose of this project is to confirm and expand on these preliminary findings in different PU risk scenarios to model the underlying inflammatory processes that reflect the individual vulnerability of the skin caused by pressure exposure and use modeling to extract a new layer of mechanistic insights of the underlying inflammatory process in different patient populations. The specific aims of the project are: 1. To establish and validate optimal combinations of molecular biomarkers to identify individual susceptibility to pressure exposure during routine management regimes related to medical devises non-invasive ventilation (NIV) therapy. 2. To unravel key mechanisms in inflammatory processes related to early tissue damage by developing a mathematical model for the timing of events in the response to pressure, based on collected biomolecules, earlier data, and interaction databases 3. To identify risk factors of PU vulnerability on an individual level in routine clinical settings by combining biomolecules, model-based simulations, and clinical parameters

Interventions

PROCEDUREnon-invasive ventilation teraphy, NIV

Routine management regimes of NIV

Sponsors

Region Östergötland
CollaboratorOTHER
Linkoeping University
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- patients that use oronasal face masks in their ordinary care during routine management regimes of non invasive ventilation.

Exclusion criteria

* acute respiratory failure * previous ICU care * pressure ulcer on measurement site

Design outcomes

Primary

MeasureTime frameDescription
CTACK2 minutesinflammatory biomarker
ENA-782 minutesinflammatory biomarker
Eotaxin2 minutesinflammatory biomarker
Eotaxin-22 minutesinflammatory biomarker
Eotaxin-32 minutesinflammatory biomarker
EPO2 minutesinflammatory biomarker
FLT3L2 minutesinflammatory biomarker
Fractalkine2 minutesinflammatory biomarker
G-CSF2 minutesinflammatory biomarker
GM-CSF2 minutesinflammatory biomarker
GRO-alpha2 minutesinflammatory biomarker
I-3092 minutesinflammatory biomarker
IFN-α2a2 minutesinflammatory biomarker
IFN-β2 minutesinflammatory biomarker
IFN-γ2 minutesinflammatory biomarker
IL-102 minutesinflammatory biomarker
IL-12/IL-23p402 minutesinflammatory biomarker
IL-12p702 minutesinflammatory biomarker
IL-132 minutesinflammatory biomarker
IL-152 minutesinflammatory biomarker
IL-162 minutesinflammatory biomarker
IL-17A2 minutesinflammatory biomarker
IL-17A/F2 minutesinflammatory biomarker
IL-17B2 minutesinflammatory biomarker
IL-17C2 minutesinflammatory biomarker
IL-17D2 minutesinflammatory biomarker
IL-17E/IL-252 minutesinflammatory biomarker
IL-17F2 minutesinflammatory biomarker
IL-182 minutesinflammatory biomarker
IL-1RA2 minutesinflammatory biomarker
IL-1α2 minutesinflammatory biomarker
IL-1β2 minutesinflammatory biomarker
IL-22 minutesinflammatory biomarker
IL-212 minutesinflammatory biomarker
IL-222 minutesinflammatory biomarker
IL-232 minutesinflammatory biomarker
IL-272 minutesinflammatory biomarker
IL-29/IFN-L12 minutesinflammatory biomarker
IL-2Ra2 minutesinflammatory biomarker
IL-32 minutesinflammatory biomarker
IL-312 minutesinflammatory biomarker
IL-332 minutesinflammatory biomarker
IL-42 minutesinflammatory biomarker
IL-52 minutesinflammatory biomarker
IL-62 minutesinflammatory biomarker
IL-72 minutesinflammatory biomarker
IL-82 minutesinflammatory biomarker
IL-92 minutesinflammatory biomarker
IP-102 minutesinflammatory biomarker
I-TAC2 minutesinflammatory biomarker
MCP-12 minutesinflammatory biomarker
MCP-22 minutesinflammatory biomarker
MCP-32 minutesinflammatory biomarker
MCP-42 minutesinflammatory biomarker
M-CSF2 minutesinflammatory biomarker
MDC2 minutesinflammatory biomarker
MIF2 minutesinflammatory biomarker
MIP-1α2 minutesinflammatory biomarker
MIP-1β2 minutesinflammatory biomarker
MIP-3α2 minutesinflammatory biomarker
MIP-3β2 minutesinflammatory biomarker
MIP-52 minutesinflammatory biomarker
SDF-1alpha2 minutesinflammatory biomarker
TARC2 minutesinflammatory biomarker
TNF-α2 minutesinflammatory biomarker
TNF-β2 minutesinflammatory biomarker
TPO2 minutesinflammatory biomarker
TRAIL2 minutesinflammatory biomarker
TSLP2 minutesinflammatory biomarker
VEGF-A2 minutesinflammatory biomarker
YKL-402 minutesinflammatory biomarker

Countries

Sweden

Contacts

Primary ContactSara Bergstrand, PhD
sara.bergstrand@liu.se+4613286773

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026