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Detecting Changes in Skin Status Over the Site of a Stage 1 Pressure Ulcer Using Biophysical Sensors and Biomarkers

NCT06420102 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-05-17

No results posted yet for this study

Summary

During a patient's hospital stay the skin can be exposed to forces from sitting or lying and attachment to different medical devices. Skin health is maintained healthy through regular movements to remove pressure from the skin surface. However, sometimes if the skin is exposed to loads for prolonged periods, it can be compromised, and red marks can appear (stage one pressure ulcer). In most cases, these changes in the skin can be recovered, through regular movement and nursing care. However, in a small number of cases, the skin damage can progress further until a wound appears. It is important to find out why this may occur, so that preventive strategies can be implemented to protect skin health. Therefore, the project focuses on evaluating changes in skin health following the development of a minor pressure ulcer (stage one).

This research proposal aims to better understand how the skin changes at the body sites compromised by stage 1 pressure ulcer, compared to healthy sites. This will be achieved via the use of measurements of skin health including physical sensors and sampling fluids and cells from the skin surface. The knowledge acquired from this study will help the understanding of how and why skin breaks down following early signs of damage. Some of the proposed sensing systems could then be used to support healthcare professionals to adopt the appropriate preventive strategies to avoid skin damage and subsequent wounds. A cohort of 50 patients will be recruited from a hospital setting, who present with a stage one pressure ulcer. Skin measurements will be taken three times to establish changes during their hospital stay. The investigators will establish if these measurements support the prediction of whether the stage one ulcer heals, remains the same, or progresses into a wound (stage two or higher pressure ulcer).

Conditions

  • Pressure Ulcer

Interventions

DIAGNOSTIC_TEST

Biophysical and biochemical skin assessment

Measurements are taken from the skin surface including transepidermal water loss, skin hydration and pH. In addition, non-invasive biofluid (sebum) is sampled from the skin to profile local inflammation. Skin surface cells were also stripped to assess corneocyte properties over the pressure ulcer and surrounding healthy skin.

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER

  • University of Southampton

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2023-03-10
Completion
2023-07-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06420102 on ClinicalTrials.gov