Clinical trial NCT06468306: Combined Molecular and Mechanistic Methods for Detection of Pressure Ulcers
Official title: Combined Molecular and Mechanistic Methods for Early Detection and Individual Prevention of Pressure Ulcer Formation in Vulnerable Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pressure Ulcer
Inflammatory Response
Keywords: Pressure Ulcer
nursing
prevention
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Region Östergötland
First posted: 2024-06-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that use oronasal face masks in their ordinary care during routine management regimes of non invasive ventilation.

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

Eligibility criteria: 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

Primary outcomes:
measure: CTACK
timeFrame: 2 minutes
measure: ENA-78
timeFrame: 2 minutes
measure: Eotaxin
timeFrame: 2 minutes
measure: Eotaxin-2
timeFrame: 2 minutes
measure: Eotaxin-3
timeFrame: 2 minutes
measure: EPO
timeFrame: 2 minutes
measure: FLT3L
timeFrame: 2 minutes
measure: Fractalkine
timeFrame: 2 minutes
measure: G-CSF
timeFrame: 2 minutes
measure: GM-CSF
timeFrame: 2 minutes
measure: GRO-alpha
timeFrame: 2 minutes
measure: I-309
timeFrame: 2 minutes
measure: IFN-α2a
timeFrame: 2 minutes
measure: IFN-β
timeFrame: 2 minutes
measure: IFN-γ
timeFrame: 2 minutes
measure: IL-10
timeFrame: 2 minutes
measure: IL-12/IL-23p40
timeFrame: 2 minutes
measure: IL-12p70
timeFrame: 2 minutes
measure: IL-13
timeFrame: 2 minutes
measure: IL-15
timeFrame: 2 minutes
measure: IL-16
timeFrame: 2 minutes
measure: IL-17A
timeFrame: 2 minutes
measure: IL-17A/F
timeFrame: 2 minutes
measure: IL-17B
timeFrame: 2 minutes
measure: IL-17C
timeFrame: 2 minutes
measure: IL-17D
timeFrame: 2 minutes
measure: IL-17E/IL-25
timeFrame: 2 minutes
measure: IL-17F
timeFrame: 2 minutes
measure: IL-18
timeFrame: 2 minutes
measure: IL-1RA
timeFrame: 2 minutes
measure: IL-1α
timeFrame: 2 minutes
measure: IL-1β
timeFrame: 2 minutes
measure: IL-2
timeFrame: 2 minutes
measure: IL-21
timeFrame: 2 minutes
measure: IL-22
timeFrame: 2 minutes
measure: IL-23
timeFrame: 2 minutes
measure: IL-27
timeFrame: 2 minutes
measure: IL-29/IFN-L1
timeFrame: 2 minutes
measure: IL-2Ra
timeFrame: 2 minutes
measure: IL-3
timeFrame: 2 minutes
measure: IL-31
timeFrame: 2 minutes
measure: IL-33
timeFrame: 2 minutes
measure: IL-4
timeFrame: 2 minutes
measure: IL-5
timeFrame: 2 minutes
measure: IL-6
timeFrame: 2 minutes
measure: IL-7
timeFrame: 2 minutes
measure: IL-8
timeFrame: 2 minutes
measure: IL-9
timeFrame: 2 minutes
measure: IP-10
timeFrame: 2 minutes
measure: I-TAC
timeFrame: 2 minutes
measure: MCP-1
timeFrame: 2 minutes
measure: MCP-2
timeFrame: 2 minutes
measure: MCP-3
timeFrame: 2 minutes
measure: MCP-4
timeFrame: 2 minutes
measure: M-CSF
timeFrame: 2 minutes
measure: MDC
timeFrame: 2 minutes
measure: MIF
timeFrame: 2 minutes
measure: MIP-1α
timeFrame: 2 minutes
measure: MIP-1β
timeFrame: 2 minutes
measure: MIP-3α
timeFrame: 2 minutes
measure: MIP-3β
timeFrame: 2 minutes
measure: MIP-5
timeFrame: 2 minutes
measure: SDF-1alpha
timeFrame: 2 minutes
measure: TARC
timeFrame: 2 minutes
measure: TNF-α
timeFrame: 2 minutes
measure: TNF-β
timeFrame: 2 minutes
measure: TPO
timeFrame: 2 minutes
measure: TRAIL
timeFrame: 2 minutes
measure: TSLP
timeFrame: 2 minutes
measure: VEGF-A
timeFrame: 2 minutes
measure: YKL-40
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
Study officials:
affiliation: Linkoeping University
name: Sara Bergstrand, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kallman U, Bergstrand S, Ek AC, Engstrom M, Lindgren M. Blood flow responses over sacrum in nursing home residents during one hour bed rest. Microcirculation. 2016 Oct;23(7):530-539. doi: 10.1111/micc.12303.
citation: Feldt A, Kohler AK, Bergstrand S. Nurses' strategies to enable continuous positive airway pressure therapy in a general medical ward context: A qualitative study. Scand J Caring Sci. 2023 Jun;37(2):524-533. doi: 10.1111/scs.13136. Epub 2022 Nov 28.
citation: John AJUK, Galdo FD, Gush R, Worsley PR. An evaluation of mechanical and biophysical skin parameters at different body locations. Skin Res Technol. 2023 Feb;29(2):e13292. doi: 10.1111/srt.13292.
citation: Jayabal H, Bader DL, Worsley P. Development of an Efficient Extraction Methodology to Analyse Potential Inflammatory Biomarkers from Sebum. Skin Pharmacol Physiol. 2023;36(1):38-50. doi: 10.1159/000528653. Epub 2022 Dec 26.