Combined Molecular and Mechanistic Methods for Early Detection and Individual Prevention of Pressure Ulcer Formation in Vulnerable Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- TNF-β
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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
- To identify risk factors of PU vulnerability on an individual level in routine clinical settings by combining biomolecules, model-based simulations, and clinical parameters
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
TNF-β
时间窗: 2 minutes
inflammatory biomarker
TPO
时间窗: 2 minutes
inflammatory biomarker
YKL-40
时间窗: 2 minutes
inflammatory biomarker
IL-17B
时间窗: 2 minutes
inflammatory biomarker
IL-17D
时间窗: 2 minutes
inflammatory biomarker
IL-17F
时间窗: 2 minutes
inflammatory biomarker
IL-18
时间窗: 2 minutes
inflammatory biomarker
IL-1RA
时间窗: 2 minutes
inflammatory biomarker
IL-1α
时间窗: 2 minutes
inflammatory biomarker
IL-1β
时间窗: 2 minutes
inflammatory biomarker
IL-33
时间窗: 2 minutes
inflammatory biomarker
IL-5
时间窗: 2 minutes
inflammatory biomarker
MCP-4
时间窗: 2 minutes
inflammatory biomarker
M-CSF
时间窗: 2 minutes
inflammatory biomarker
MDC
时间窗: 2 minutes
inflammatory biomarker
MIF
时间窗: 2 minutes
inflammatory biomarker
MIP-3β
时间窗: 2 minutes
inflammatory biomarker
SDF-1alpha
时间窗: 2 minutes
inflammatory biomarker
GM-CSF
时间窗: 2 minutes
inflammatory biomarker
GRO-alpha
时间窗: 2 minutes
inflammatory biomarker
I-309
时间窗: 2 minutes
inflammatory biomarker
IL-2
时间窗: 2 minutes
inflammatory biomarker
IL-27
时间窗: 2 minutes
inflammatory biomarker
IL-3
时间窗: 2 minutes
inflammatory biomarker
IL-31
时间窗: 2 minutes
inflammatory biomarker
IL-9
时间窗: 2 minutes
inflammatory biomarker
MIP-1α
时间窗: 2 minutes
inflammatory biomarker
I-TAC
时间窗: 2 minutes
inflammatory biomarker
ENA-78
时间窗: 2 minutes
inflammatory biomarker
MCP-2
时间窗: 2 minutes
inflammatory biomarker
MIP-3α
时间窗: 2 minutes
inflammatory biomarker
IFN-α2a
时间窗: 2 minutes
inflammatory biomarker
IFN-γ
时间窗: 2 minutes
inflammatory biomarker
IL-15
时间窗: 2 minutes
inflammatory biomarker
IL-17E/IL-25
时间窗: 2 minutes
inflammatory biomarker
IL-23
时间窗: 2 minutes
inflammatory biomarker
IL-7
时间窗: 2 minutes
inflammatory biomarker
IL-8
时间窗: 2 minutes
inflammatory biomarker
TARC
时间窗: 2 minutes
inflammatory biomarker
CTACK
时间窗: 2 minutes
inflammatory biomarker
Eotaxin
时间窗: 2 minutes
inflammatory biomarker
FLT3L
时间窗: 2 minutes
inflammatory biomarker
Fractalkine
时间窗: 2 minutes
inflammatory biomarker
G-CSF
时间窗: 2 minutes
inflammatory biomarker
IFN-β
时间窗: 2 minutes
inflammatory biomarker
IL-21
时间窗: 2 minutes
inflammatory biomarker
IL-29/IFN-L1
时间窗: 2 minutes
inflammatory biomarker
IL-2Ra
时间窗: 2 minutes
inflammatory biomarker
IL-6
时间窗: 2 minutes
inflammatory biomarker
Eotaxin-3
时间窗: 2 minutes
inflammatory biomarker
Eotaxin-2
时间窗: 2 minutes
inflammatory biomarker
IL-17A
时间窗: 2 minutes
inflammatory biomarker
IL-17A/F
时间窗: 2 minutes
inflammatory biomarker
IL-17C
时间窗: 2 minutes
inflammatory biomarker
IL-22
时间窗: 2 minutes
inflammatory biomarker
IL-4
时间窗: 2 minutes
inflammatory biomarker
IP-10
时间窗: 2 minutes
inflammatory biomarker
MCP-1
时间窗: 2 minutes
inflammatory biomarker
MCP-3
时间窗: 2 minutes
inflammatory biomarker
TNF-α
时间窗: 2 minutes
inflammatory biomarker
EPO
时间窗: 2 minutes
inflammatory biomarker
IL-10
时间窗: 2 minutes
inflammatory biomarker
IL-12/IL-23p40
时间窗: 2 minutes
inflammatory biomarker
IL-12p70
时间窗: 2 minutes
inflammatory biomarker
IL-13
时间窗: 2 minutes
inflammatory biomarker
IL-16
时间窗: 2 minutes
inflammatory biomarker
MIP-1β
时间窗: 2 minutes
inflammatory biomarker
MIP-5
时间窗: 2 minutes
inflammatory biomarker
TRAIL
时间窗: 2 minutes
inflammatory biomarker
TSLP
时间窗: 2 minutes
inflammatory biomarker
VEGF-A
时间窗: 2 minutes
inflammatory biomarker
次要结局
未报告次要终点
研究者
Sara Bergstrand
Senior Associate Professor
Linkoeping University