Combined Molecular and Mechanistic Methods for Detection of Pressure Ulcers

NCT ID: NCT06468306

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2027-12-30

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

Conditions

Pressure Ulcer; Inflammatory Response

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

non-invasive ventilation teraphy, NIV

Intervention Type: PROCEDURE

Routine management regimes of NIV

Interventions

non-invasive ventilation teraphy, NIV

Routine management regimes of NIV

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Östergötland

OTHER

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sara Bergstrand

Senior Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Bergstrand, PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

Linköping University

Linköping, , Sweden

Countries

Sweden

Central Contacts

Sara Bergstrand, PhD

Role: CONTACT

sara.bergstrand@liu.se

+4613286773

References

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.

Reference Type: BACKGROUND

PMID: 27534925 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36440591 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36823505 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36572004 (View on PubMed)

Other Identifiers

2023-07341-01

Identifier Type: -

Identifier Source: org_study_id