Combined Molecular and Mechanistic Methods for Detection of Pressure Ulcers

Inflammatory Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06468306
• Other study ID #: 2023-07341-01
• Status: Not yet recruiting
• Start date: August 1, 2024
• Est. completion date: December 30, 2027

Study information

• Verified date: June 2024
• Source: Linkoeping University
• Contact: Sara Bergstrand, PhD
• Phone: +4613286773
• Email: sara.bergstrand[@]liu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Response
• Pressure Ulcer
• Ulcer

Intervention

Procedure:
• non-invasive ventilation teraphy, NIV
Routine management regimes of NIV

Locations

Country	Name	City	State
Sweden	Linköping University	Linköping

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	Region Östergötland

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CTACK	inflammatory biomarker	2 minutes
Primary	ENA-78	inflammatory biomarker	2 minutes
Primary	Eotaxin	inflammatory biomarker	2 minutes
Primary	Eotaxin-2	inflammatory biomarker	2 minutes
Primary	Eotaxin-3	inflammatory biomarker	2 minutes
Primary	EPO	inflammatory biomarker	2 minutes
Primary	FLT3L	inflammatory biomarker	2 minutes
Primary	Fractalkine	inflammatory biomarker	2 minutes
Primary	G-CSF	inflammatory biomarker	2 minutes
Primary	GM-CSF	inflammatory biomarker	2 minutes
Primary	GRO-alpha	inflammatory biomarker	2 minutes
Primary	I-309	inflammatory biomarker	2 minutes
Primary	IFN-a2a	inflammatory biomarker	2 minutes
Primary	IFN-ß	inflammatory biomarker	2 minutes
Primary	IFN-?	inflammatory biomarker	2 minutes
Primary	IL-10	inflammatory biomarker	2 minutes
Primary	IL-12/IL-23p40	inflammatory biomarker	2 minutes
Primary	IL-12p70	inflammatory biomarker	2 minutes
Primary	IL-13	inflammatory biomarker	2 minutes
Primary	IL-15	inflammatory biomarker	2 minutes
Primary	IL-16	inflammatory biomarker	2 minutes
Primary	IL-17A	inflammatory biomarker	2 minutes
Primary	IL-17A/F	inflammatory biomarker	2 minutes
Primary	IL-17B	inflammatory biomarker	2 minutes
Primary	IL-17C	inflammatory biomarker	2 minutes
Primary	IL-17D	inflammatory biomarker	2 minutes
Primary	IL-17E/IL-25	inflammatory biomarker	2 minutes
Primary	IL-17F	inflammatory biomarker	2 minutes
Primary	IL-18	inflammatory biomarker	2 minutes
Primary	IL-1RA	inflammatory biomarker	2 minutes
Primary	IL-1a	inflammatory biomarker	2 minutes
Primary	IL-1ß	inflammatory biomarker	2 minutes
Primary	IL-2	inflammatory biomarker	2 minutes
Primary	IL-21	inflammatory biomarker	2 minutes
Primary	IL-22	inflammatory biomarker	2 minutes
Primary	IL-23	inflammatory biomarker	2 minutes
Primary	IL-27	inflammatory biomarker	2 minutes
Primary	IL-29/IFN-L1	inflammatory biomarker	2 minutes
Primary	IL-2Ra	inflammatory biomarker	2 minutes
Primary	IL-3	inflammatory biomarker	2 minutes
Primary	IL-31	inflammatory biomarker	2 minutes
Primary	IL-33	inflammatory biomarker	2 minutes
Primary	IL-4	inflammatory biomarker	2 minutes
Primary	IL-5	inflammatory biomarker	2 minutes
Primary	IL-6	inflammatory biomarker	2 minutes
Primary	IL-7	inflammatory biomarker	2 minutes
Primary	IL-8	inflammatory biomarker	2 minutes
Primary	IL-9	inflammatory biomarker	2 minutes
Primary	IP-10	inflammatory biomarker	2 minutes
Primary	I-TAC	inflammatory biomarker	2 minutes
Primary	MCP-1	inflammatory biomarker	2 minutes
Primary	MCP-2	inflammatory biomarker	2 minutes
Primary	MCP-3	inflammatory biomarker	2 minutes
Primary	MCP-4	inflammatory biomarker	2 minutes
Primary	M-CSF	inflammatory biomarker	2 minutes
Primary	MDC	inflammatory biomarker	2 minutes
Primary	MIF	inflammatory biomarker	2 minutes
Primary	MIP-1a	inflammatory biomarker	2 minutes
Primary	MIP-1ß	inflammatory biomarker	2 minutes
Primary	MIP-3a	inflammatory biomarker	2 minutes
Primary	MIP-3ß	inflammatory biomarker	2 minutes
Primary	MIP-5	inflammatory biomarker	2 minutes
Primary	SDF-1alpha	inflammatory biomarker	2 minutes
Primary	TARC	inflammatory biomarker	2 minutes
Primary	TNF-a	inflammatory biomarker	2 minutes
Primary	TNF-ß	inflammatory biomarker	2 minutes
Primary	TPO	inflammatory biomarker	2 minutes
Primary	TRAIL	inflammatory biomarker	2 minutes
Primary	TSLP	inflammatory biomarker	2 minutes
Primary	VEGF-A	inflammatory biomarker	2 minutes
Primary	YKL-40	inflammatory biomarker	2 minutes