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

NCT06420102 | Completed

• 1 other identifier: ERGO 66933
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Spatial and temporal differences in skin barrier function over a grade 1 pressure ulcer

  Case controlled differences in transepidermal water loss between the site of a grade 1 pressure ulcer and health adjacent skin. A Tewameter (CK, Germany) was used to assess skin barrier function sampled over a 30 second period. This was measured over the site of the grade 1 pressure ulcer and one that was 10cm lateral (healthy site). This outcome was measured in g/m2/hr.

  3 weeks.

Secondary Outcomes (4)

• Spatial differences in skin corneocyte topography over a grade 1 pressure ulcer

  3 weeks.

• Spatial differences in skin corneocyte maturity over a grade 1 pressure ulcer

  3 weeks.

• Spatial and temporal differences in skin inflammation over a grade 1 pressure ulcer

  3 weeks

• Spatial and temporal differences in skin hydration over a grade 1 pressure ulcer

  3 weeks.

Study Arms (1)

Grade 1 pressure ulcer cohort

Individuals who are in hospital that present with a confirm grade 1 pressure ulcer. These include a range of sex, age and ethnicities.

Diagnostic Test: Biophysical and biochemical skin assessment

Interventions

Biophysical and biochemical skin assessment DIAGNOSTIC_TEST

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.

Also known as: Corneocyte evaluation

Grade 1 pressure ulcer cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be purposefully sampled from a number of departments/units at University Hospital Southampton (UHS) Foundation Trust. According to information from the Tissue Viability Department, an average number of 50 patients are referred monthly with presentations of early signs of PUs. The study is designed to recruit 50 participants over a 12-month period

You may qualify if:

• Aged over 18 years old
• Individuals of all genders and ethnicities
• Individuals presenting grade 1 PU (regardless of the anatomical location of the PU)
• Individuals admitted to UHST
• Have the capacity and English proficiency to provide informed consent

You may not qualify if:

• Individuals with broken skin
• Patients at end of life
• Patients who cannot be repositioned due to medical reasons
• Patients in COVID-19 areas
• Allergies or sensitivity to sebutape or Sellotape
• Current active skin condition on the areas of measurement
• Cognitive impairments which limit their ability to provide informed consent
• Inability to understand English language

Sponsors & Collaborators

• University of Southampton: lead
• European Union: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator

Study Sites (1)

University Hospital Southampton (UHS) Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (2)

• Jayabal H, Abiakam NS, Filingeri D, Bader DL, Worsley PR. Inflammatory biomarkers in sebum for identifying skin damage in patients with a Stage I pressure ulcer in the pelvic region: A single centre observational, longitudinal cohort study with elderly patients. Int Wound J. 2023 Sep;20(7):2594-2607. doi: 10.1111/iwj.14131. Epub 2023 Mar 5.

  PMID: 36872612 BACKGROUND

• Abiakam NS, Jayabal H, Filingeri D, Bader DL, Worsley PR. Spatial and temporal changes in biophysical skin parameters over a category I pressure ulcer. Int Wound J. 2023 Oct;20(8):3164-3176. doi: 10.1111/iwj.14194. Epub 2023 Apr 14.

  PMID: 37060199 RESULT

Related Links

• STINTS EU Marie Curie ITN funding home page

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: May 17, 2024
• Study Start: November 16, 2021
• Primary Completion: March 10, 2023
• Study Completion: July 1, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)