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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Response; Pressure Ulcer
• Intervention / Treatment: Procedure: non-invasive ventilation teraphy, NIV

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

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Sara Bergstrand, PhD; Phone Number: +4613286773; Email: sara.bergstrand@liu.se

Study Locations

• Sweden
  • Linköping, Sweden, 58183
    • Linköping University
    • Principal Investigator: Sara Bergstrand, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
individuals with NIV treatment; Patients that use oronasal face masks in their ordinary care to measure early-stage medical devise-related tissue damage during routine management regimes of NIV. Approximately 150 adult patients of both sexes will be recruited, from facilities that employ oronasal face masks in the routine care.	Procedure: non-invasive ventilation teraphy, NIV; Routine management regimes of NIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CTACK	inflammatory biomarker	2 minutes
ENA-78	inflammatory biomarker	2 minutes
Eotaxin	inflammatory biomarker	2 minutes
Eotaxin-2	inflammatory biomarker	2 minutes
Eotaxin-3	inflammatory biomarker	2 minutes
EPO	inflammatory biomarker	2 minutes
FLT3L	inflammatory biomarker	2 minutes
Fractalkine	inflammatory biomarker	2 minutes
G-CSF	inflammatory biomarker	2 minutes
GM-CSF	inflammatory biomarker	2 minutes
GRO-alpha	inflammatory biomarker	2 minutes
I-309	inflammatory biomarker	2 minutes
IFN-α2a	inflammatory biomarker	2 minutes
IFN-β	inflammatory biomarker	2 minutes
IFN-γ	inflammatory biomarker	2 minutes
IL-10	inflammatory biomarker	2 minutes
IL-12/IL-23p40	inflammatory biomarker	2 minutes
IL-12p70	inflammatory biomarker	2 minutes
IL-13	inflammatory biomarker	2 minutes
IL-15	inflammatory biomarker	2 minutes
IL-16	inflammatory biomarker	2 minutes
IL-17A	inflammatory biomarker	2 minutes
IL-17A/F	inflammatory biomarker	2 minutes
IL-17B	inflammatory biomarker	2 minutes
IL-17C	inflammatory biomarker	2 minutes
IL-17D	inflammatory biomarker	2 minutes
IL-17E/IL-25	inflammatory biomarker	2 minutes
IL-17F	inflammatory biomarker	2 minutes
IL-18	inflammatory biomarker	2 minutes
IL-1RA	inflammatory biomarker	2 minutes
IL-1α	inflammatory biomarker	2 minutes
IL-1β	inflammatory biomarker	2 minutes
IL-2	inflammatory biomarker	2 minutes
IL-21	inflammatory biomarker	2 minutes
IL-22	inflammatory biomarker	2 minutes
IL-23	inflammatory biomarker	2 minutes
IL-27	inflammatory biomarker	2 minutes
IL-29/IFN-L1	inflammatory biomarker	2 minutes
IL-2Ra	inflammatory biomarker	2 minutes
IL-3	inflammatory biomarker	2 minutes
IL-31	inflammatory biomarker	2 minutes
IL-33	inflammatory biomarker	2 minutes
IL-4	inflammatory biomarker	2 minutes
IL-5	inflammatory biomarker	2 minutes
IL-6	inflammatory biomarker	2 minutes
IL-7	inflammatory biomarker	2 minutes
IL-8	inflammatory biomarker	2 minutes
IL-9	inflammatory biomarker	2 minutes
IP-10	inflammatory biomarker	2 minutes
I-TAC	inflammatory biomarker	2 minutes
MCP-1	inflammatory biomarker	2 minutes
MCP-2	inflammatory biomarker	2 minutes
MCP-3	inflammatory biomarker	2 minutes
MCP-4	inflammatory biomarker	2 minutes
M-CSF	inflammatory biomarker	2 minutes
MDC	inflammatory biomarker	2 minutes
MIF	inflammatory biomarker	2 minutes
MIP-1α	inflammatory biomarker	2 minutes
MIP-1β	inflammatory biomarker	2 minutes
MIP-3α	inflammatory biomarker	2 minutes
MIP-3β	inflammatory biomarker	2 minutes
MIP-5	inflammatory biomarker	2 minutes
SDF-1alpha	inflammatory biomarker	2 minutes
TARC	inflammatory biomarker	2 minutes
TNF-α	inflammatory biomarker	2 minutes
TNF-β	inflammatory biomarker	2 minutes
TPO	inflammatory biomarker	2 minutes
TRAIL	inflammatory biomarker	2 minutes
TSLP	inflammatory biomarker	2 minutes
VEGF-A	inflammatory biomarker	2 minutes
YKL-40	inflammatory biomarker	2 minutes

Collaborators and Investigators

• Sponsor: Linkoeping University
• Collaborators: Region Östergötland
• Investigators: Principal Investigator: Sara Bergstrand, PhD, Linkoeping University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: prevention; nursing; Pressure Ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: 2023-07341-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IDP data will be shared outside the research group

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No