Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468306
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-04
Brief Title:
Combined Molecular and Mechanistic Methods for Detection of Pressure Ulcers
Sponsor:
Linkoeping University
Organization:
Linkoeping University
Study Overview
Official Title:
Combined Molecular and Mechanistic Methods for Early Detection and Individual Prevention of Pressure Ulcer Formation in Vulnerable Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 countrys 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None