Pressure UlcerNCT06420102
Detecting Changes in Skin Status Over the Site of a Stage 1 Pressure Ulcer Using Biophysical Sensors and Biomarkers
An observational study of Pressure Ulcer, run by University of Southampton at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Biophysical and biochemical skin assessment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Nov 2021to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton (UHS) Foundation Trust
Southampton, Hampshire, SO16 6YD
About this study
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).
Read the detailed description
This is a case controlled longitudinal observational study on patients who have the early signs of pressure ulcers, termed stage 1. In this study, a series of non-invasive measurements will be performed to assess skin status in individuals presenting with stage 1 pressure ulcers (PU). Photographic images of the compromised skin site of participants will also be collected. Participants will be tested using a well-established protocol, which consist of visiting the patient on three different occasions during their hospital stay. The first two visits will be on consecutive days while the third skin assessment session will be carried out a day before the patient is discharged. The investigator team will ensure that the sessions, which will last approximately 15-20 minutes, avoiding any interference with patients personal or healthcare commitments.
Different measurements on the participant skin surface will be taken using probes which are designed to monitor skin health (all probes are CE marked and have been employed previously in clinical trials). The measurements will include:
- the pH (acidity) at the skin surface
- the amount of water which is lost through the skin
- skin hydration
In addition, sebum (oily substance) and cells from the compromised and healthy areas of the skin using commercial tapes were collected. The aforementioned skin parameters will be taken at each visit using non-invasive, harmless wireless probes, which will be placed gently in contact with the skin for a 1-minute duration. Each probe was cleaned in-between assessments following the NHS infection control policies. Skin sebum will also be taken at each assessment from the areas of interest using sebutapes, which will be gently applied to the skin for 2 minutes before removal. These commercially available tapes have been used extensively in dermatological research. Corneocytes (outermost surface cells) will be taken only on the first visit from both the compromised and healthy sites of the skin. This will be achieved using a harmless tape stripping technique during which standard sellotapes will be applied to the skin surface and slightly pressed for 5 seconds prior to removal.
- Conditions
- Pressure Ulcer
- Being tested
- Biophysical and biochemical skin assessment
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biophysical and biochemical skin assessmentDiagnostic test
Also called Corneocyte evaluation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Biophysical and biochemical skin assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks.
Secondary outcomes (4)
Spatial differences in skin corneocyte topography over a grade 1 pressure ulcer
Case controlled differences in the maturity of corneocyte cells over a grade 1 pressure ulcer. Cells were collected from a PU-compromised site and an adjacent control area and their topographical properties were analysed. Atomic force microscopy (AFM) imaging and nanoindentation experiments were performed to assess topography.
Measured: 3 weeks.
Spatial differences in skin corneocyte maturity over a grade 1 pressure ulcer
Case controlled differences in the maturity of corneocyte cells over a grade 1 pressure ulcer. Cells were collected from a PU-compromised site and an adjacent control area and maturation properties were analysed. Maturity of corneodesmosomes was indirectly measured by immunostaining of desmoglein-1 (Dsg1). Parameters of measurement included surface roughness Sq (nm) and Youngs Modulus of cells (MPa). Qualitative analysis of immunostaining of desmoglein-1 (Dsg1) was also included.
Measured: 3 weeks.
Spatial and temporal differences in skin inflammation over a grade 1 pressure ulcer
Case controlled differences in skin inflammatory biomarkers between the site of a grade 1 pressure ulcer and health adjacent skin. Sebutapes were collected over three sessions to investigate the temporal changes in the inflammatory response. The panel of cytokines investigated included high-abundance cytokines, namely, IL-1α and IL-1RA, and low abundance cytokines; IL-6, IL-8, TNF-α, INF-γ, IL-33, IL-1β and G-CSF. Spatial and temporal differences between sites were assessed and thresholds were used to determine the sensitivity and specificity of each biomarker. Concentrations of protein biomarkers in the sebum will be presented in picograms per ml.
Measured: 3 weeks
Spatial and temporal differences in skin hydration over a grade 1 pressure ulcer
Case controlled differences in skin hydration between the site of a grade 1 pressure ulcer and health adjacent skin. A Corneometer (CK, Germany) was used to assess skin hydration sampled 5 times over eac site. This was measured over the site of the grade 1 pressure ulcer and one that was 10cm lateral (healthy site). Stratum corneum hydration was measured in arbitrary units, according to the calibrated Corneometer.
Measured: 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start16 Nov 2021
- Primary completion10 Mar 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420102
- Sponsor's protocol ID
- ERGO 66933
- Status last verified
- May 2024
- First submitted
- 23 Aug 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As per University of Southampton and EU guidelines anonymised from the study can be accessed through our ePrints provider.
Publications
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.
PubMed 36872612Abiakam 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.
PubMed 37060199
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Changes in Skin Status Over the Site of a Stage 1 Pressure Ulcer Using Biophysical Sensors and Biomarkers
- ClinicalTrials.gov ID
- NCT06420102
- Acronym / sponsor ID
- ERGO 66933
- Conditions
- Pressure Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- European Union, University Hospital Southampton NHS Foundation Trust
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a case controlled longitudinal observational study on patients who have the early signs of pressure ulcers, termed stage 1. In this study, a series of non-invasive measurements will be performed to assess skin status in individuals presenting with stage 1 pressure ulcers (PU). Photographic images of the compromised skin site of participants will also be collected. Participants will be tested using a well-established protocol, which consist of visiting the patient on three different occasions during their hospital stay. The first two visits will be on consecutive days while the third skin assessment session will be carried out a day before the patient is discharged. The investigator team will ensure that the sessions, which will last approximately 15-20 minutes, avoiding any interference with patients personal or healthcare commitments.
Different measurements on the participant skin surface will be taken using probes which are designed to monitor skin health (all probes are CE marked and have been employed previously in clinical trials). The measurements will include:
- the pH (acidity) at the skin surface
- the amount of water which is lost through the skin
- skin hydration
In addition, sebum (oily substance) and cells from the compromised and healthy areas of the skin using commercial tapes were collected. The aforementioned skin parameters will be taken at each visit using non-invasive, harmless wireless probes, which will be placed gently in contact with the skin for a 1-minute duration. Each probe was cleaned in-between assessments following the NHS infection control policies. Skin sebum will also be taken at each assessment from the areas of interest using sebutapes, which will be gently applied to the skin for 2 minutes before removal. These commercially available tapes have been used extensively in dermatological research. Corneocytes (outermost surface cells) will be taken only on the first visit from both the compromised and healthy sites of the skin. This will be achieved using a harmless tape stripping technique during which standard sellotapes will be applied to the skin surface and slightly pressed for 5 seconds prior to removal.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grade 1 pressure ulcer cohort | – | Diagnostic Test: Biophysical and biochemical skin assessmentIndividuals who are in hospital that present with a confirm grade 1 pressure ulcer. These include a range of sex, age and ethnicities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biophysical and biochemical skin assessmentAlso: Corneocyte evaluationMeasurements 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. | Diagnostic test | Grade 1 pressure ulcer cohort |
Primary outcome
Spatial and temporal differences in skin barrier function over a grade 1 pressure ulcer
Time frame: 3 weeks.
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.
4 secondary outcomes
Spatial differences in skin corneocyte topography over a grade 1 pressure ulcer
Time frame: 3 weeks.
Spatial differences in skin corneocyte maturity over a grade 1 pressure ulcer
Time frame: 3 weeks.
Spatial and temporal differences in skin inflammation over a grade 1 pressure ulcer
Time frame: 3 weeks
Spatial and temporal differences in skin hydration over a grade 1 pressure ulcer
Time frame: 3 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Background: PubMed 36872612Jayabal 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.
- Results publication: PubMed 37060199Abiakam 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.
- STINTS EU Marie Curie ITN funding home pageLink provided by the sponsor.
- Individual participant dataSharing planned: No. As per University of Southampton and EU guidelines anonymised from the study can be accessed through our ePrints provider.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial and temporal differences in skin barrier function over a grade 1 pressure ulcer (time frame: 3 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06420102, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.