Pressure InjuryPhase 2SCANNCT06127524
Skin Change Actions by Nursing
A Phase 2 study testing SEM Scanner in people with Pressure Injury, run by University of California, Los Angeles at 7 sites in United States.
Trial summary
Pressure injuries, local areas of damage to the skin and underlying soft tissue that are costly and painful, are often preventable with timely use of prevention strategies. Identifying early pressure induced tissue damage among nursing home residents by nursing staff during routine skin assessment is critical for this… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury
- What is being tested?
- SEM Scanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,733 participants
- Where
- 7 sitesUnited States
- Study dates
- 4 Dec 2022to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For intervention, must reside in nursing home at least 1 day during 8-month study period and be at least 18 years old at study start.
- For baseline period: Must reside in nursing home at least 1 day during 52-week lookback period and be at least 18 years old at study start
Who cannot join
- For intervention: Did not reside in nursing home during 8-month study period or younger than 18 years old For baseline period: Did not reside in nursing home during 52-week lookback period or younger than 18 years old
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Large proprietary nursing home chain faciity #3
Kennett Square, Pennsylvania, 19348
Large proprietary nursing home chain facility #1
Kennett Square, Pennsylvania, 19348
Large proprietary nursing home chain facility #4
Kennett Square, Pennsylvania, 19348
Large proprietary nursing home chain facility #5
Kennett Square, Pennsylvania, 19348
Large proprietary nursing home chain facility #6
Kennett Square, Pennsylvania, 19348
Large proprietary nursing home chain facility #7
Kennett Square, Pennsylvania, 19348
Large proprietary nursing home chain facilty #2
Kennett Square, Pennsylvania, 19348
About this study
Official title: Biophysical Detection of Skin Changes to Cue Pressure Injury Prevention in Nursing Homes
Pressure injuries, local areas of damage to the skin and underlying soft tissue that are costly and painful, are often preventable with timely use of prevention strategies. Identifying early pressure induced tissue damage among nursing home residents by nursing staff during routine skin assessment is critical for this process. Finding early damage can prompt nursing home staff to start prevention actions and may allow viable tissue rescue, reducing other health problems or death. We propose use of sub-epidermal moisture (SEM) measures as the cue for nursing home staff to start prevention care. SEM provides early detection of skin damage by as much as 5 to 10 days prior to other methods, eliminates the inherent structural bias in visual skin assessment for residents with dark skin tones, and demonstrates a model of care using technology innovation in poorly-resourced healthcare settings to provide bedside, real-time, point-of-care feedback that is can be used immediately by nursing staff.
In this study, nursing staff will use a device (the Provizio SEM Scanner) as part of standard skin assessments. The staff will use the values from the Provizio SEM Scanner during these assessments to decide if residents need preventive care for their skin. The study will look at these decisions and residents' subsequent health outcomes.
The study will also use information about residents' skin health and prevention actions during the 52 weeks before the study as a comparison.
Read the detailed description
Pressure injuries (PrIs), commonly located over bony prominences, are local areas of damage to the skin and underlying soft tissue (often not initially visible) caused by pressure and shear forces. These costly injuries, up to $151,000 per PrI, are associated among nursing home (NH) residents with reduced quality of life, pain, depression, and mortality. Prevalence and incidence of PrI have not declined and facility-acquired PrIs (FAPrIs) have actually increased over the last decade in NHs despite use of standardized prevention care. In fact, nursing home FAPrI rates are nearly double (5.4%) hospital FAPrI rates (2.9%).For nursing staff, the standard method of detecting changes in skin is conducting a visual assessment for skin discoloration; this visual detection coupled with risk assessment, serve as the customary trigger for initiating PrI prevention strategies. However, by the time reddened skin (erythema) is detected, significant damage is already present. The lag time between skin change associated with PrI formation and visual detection of the change eliminates the potential for PrI prevention strategies to be effective. Furthermore, visualization of potential PrIs is complicated by the challenge of discerning discoloration on persons with dark skin tones which, makes NH residents from minority or under-represented racial/ethnic groups more at-risk, thus leading to a significant health disparity. Multiple studies have shown racial/ethnic health disparities in PrI prevalence and incidence, severity, time to development and healing In fact, disparities in PrI prevalence, when comparing Black and white NH residents, are pervasive and persistent. Early detection of skin and tissue changes occurring as a PrI develops is a fundamental component in effective implementation of PrI prevention protocols.
Technological advances in biophysical measures have strengthened the capacity to detect early changes in tissue characteristics, for any skin tone, thus facilitating prevention care. A subclinical PrI can be readily identified at the dermal, and muscle tissue layers with a biophysical approach. Measurement of subepidermal moisture (SEM) using surface electrical capacitance is one biophysical method that has been shown to detect and predict early pressure damage. The SEM Scanner, a device used to date only in acute care hospitals, provides a biophysical measure of local inflammation and edema related to early pressure damage with a numerical result that serves as a cue for nursing staff to initiate PrI prevention with subsequent successful reduction and sustained decline in FAPrI incidence occurring. This technology's effectiveness has been demonstrated in hospitals; and this study will be the first to extend the use to NHs, a setting that is low in resources and desperate for assistance in this area. An embedded pragmatic stepped wedge clinical trial design will be conducted in 6 NHs within a single NH company with standardized operating procedures and PrI prevention protocols. We will examine whether SEM assessment results reflecting detection of early pressure damage can serve as an effective cue for NH nursing staff initiation of PrI prevention actions with the goal of reducing FAPrI rates over a 8-month intervention period. Specific aims are to:
Aim 1. Determine if early pressure damage detected by SEM assessment at time of visual skin observation of NH resident sacral and heel areas is effective in cueing the initiation of NH standard PrI prevention.
Aim 2. Examine the association between NH standard PrI prevention and SEM assessment and NH residents' characteristics (age, gender, risk, skin tone, race, ethnicity, BMI, Cognitive status) and their interactions on individual NH residents with regard to initiation of PrI prevention and PrI occurrence.
Aim 3. Explore if SEM usability, NH, and nursing staff characteristics influence the adoption and assimilation of early PrI detection and subsequent PrI prevention practices.
Results from this study will increase our knowledge and advance PrI prevention science and nursing practice. Furthermore, the clinical utility and relevance achieved with real world testing and staff delivery will help NHs with high PrI incidence by adding to the clarity of preventive nursing practices. These results will also be used for developing specialty policies and guidelines like the international PrI prevention clinical practice guidelines.
- Conditions
- Pressure Injury
- Being tested
- SEM Scanner
- Keywords
- Nursing homes, technology implementation, sub epidermal moisture
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEM ScannerDevice
Also called Provizio SEM Scanner
Implementation of the SEM Scanner as part of weekly standard skin assessments of sacrum and heels
| Study group | Role | What they receive |
|---|---|---|
| Nursing Home Residents in intervention | Experimental | All Nursing Home residents in the facility during the 8 month intervention period Receives: Device: SEM Scanner |
| Nursing Home Residents in baseline | No intervention | All Nursing Home residents in the facility during the 12 month baseline period |
What is being measured
The primary outcome is the main question the study is designed to answer.
New Pressure Injury Prevention Initiated
At least one Pressure Injury Prevention action newly initiated defined as electronic health record (EHR) documentation
Measured: From date of newly identified skin damage through 3 days later, assessed up to 8 months for intervention period or up to 12 months for usual care (Lookback) period
Secondary outcomes (1)
Time to Pressure Injury Prevention Initiation
Number of Days from skin assessment until EHR documentation of Pressure Injury Prevention
Measured: Number of days from date of identified skin damage through 3 days later, assessed up to 8 months for intervention period or up to 12 months for baseline period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start4 Dec 2022
- Primary completion22 Feb 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- nursing home residents residing at any time in the facility during a 12 month baseline followed by 8 month intervention
- Masking
- None (open label)
- Enrolment
- 4,733 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Duke University, East Carolina University, Boise State University
- Responsible party
- Principal investigator, Barbara Bates-Jensen, PhD, RN, FAAN, University of California, Los Angeles
- Investigators
- Barbara M Bates-Jensen, PhD, Principal investigator, Univeristy of California Los AngelesTracey L Yap, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127524
- Sponsor's protocol ID
- 22-001256
- Other IDs
- 5R01NR020487-02
- Acronym
- SCAN
- Status last verified
- Sep 2026
- First submitted
- 19 Oct 2023
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biophysical Detection of Skin Changes to Cue Pressure Injury Prevention in Nursing Homes
- ClinicalTrials.gov ID
- NCT06127524
- Acronym / sponsor ID
- SCAN / 22-001256
- Conditions
- Pressure Injury
- Keywords
- Nursing homes, technology implementation, sub epidermal moisture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,733 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Duke University, East Carolina University, Boise State University
- Study start
- 4 Dec 2022 (actual)
- Primary completion
- 22 Feb 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Posted 12 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pressure injuries, local areas of damage to the skin and underlying soft tissue that are costly and painful, are often preventable with timely use of prevention strategies. Identifying early pressure induced tissue damage among nursing home residents by nursing staff during routine skin assessment is critical for this process. Finding early damage can prompt nursing home staff to start prevention actions and may allow viable tissue rescue, reducing other health problems or death. We propose use of sub-epidermal moisture (SEM) measures as the cue for nursing home staff to start prevention care. SEM provides early detection of skin damage by as much as 5 to 10 days prior to other methods, eliminates the inherent structural bias in visual skin assessment for residents with dark skin tones, and demonstrates a model of care using technology innovation in poorly-resourced healthcare settings to provide bedside, real-time, point-of-care feedback that is can be used immediately by nursing staff.
In this study, nursing staff will use a device (the Provizio SEM Scanner) as part of standard skin assessments. The staff will use the values from the Provizio SEM Scanner during these assessments to decide if residents need preventive care for their skin. The study will look at these decisions and residents' subsequent health outcomes.
The study will also use information about residents' skin health and prevention actions during the 52 weeks before the study as a comparison.
Detailed description
Pressure injuries (PrIs), commonly located over bony prominences, are local areas of damage to the skin and underlying soft tissue (often not initially visible) caused by pressure and shear forces. These costly injuries, up to $151,000 per PrI, are associated among nursing home (NH) residents with reduced quality of life, pain, depression, and mortality. Prevalence and incidence of PrI have not declined and facility-acquired PrIs (FAPrIs) have actually increased over the last decade in NHs despite use of standardized prevention care. In fact, nursing home FAPrI rates are nearly double (5.4%) hospital FAPrI rates (2.9%).For nursing staff, the standard method of detecting changes in skin is conducting a visual assessment for skin discoloration; this visual detection coupled with risk assessment, serve as the customary trigger for initiating PrI prevention strategies. However, by the time reddened skin (erythema) is detected, significant damage is already present. The lag time between skin change associated with PrI formation and visual detection of the change eliminates the potential for PrI prevention strategies to be effective. Furthermore, visualization of potential PrIs is complicated by the challenge of discerning discoloration on persons with dark skin tones which, makes NH residents from minority or under-represented racial/ethnic groups more at-risk, thus leading to a significant health disparity. Multiple studies have shown racial/ethnic health disparities in PrI prevalence and incidence, severity, time to development and healing In fact, disparities in PrI prevalence, when comparing Black and white NH residents, are pervasive and persistent. Early detection of skin and tissue changes occurring as a PrI develops is a fundamental component in effective implementation of PrI prevention protocols.
Technological advances in biophysical measures have strengthened the capacity to detect early changes in tissue characteristics, for any skin tone, thus facilitating prevention care. A subclinical PrI can be readily identified at the dermal, and muscle tissue layers with a biophysical approach. Measurement of subepidermal moisture (SEM) using surface electrical capacitance is one biophysical method that has been shown to detect and predict early pressure damage. The SEM Scanner, a device used to date only in acute care hospitals, provides a biophysical measure of local inflammation and edema related to early pressure damage with a numerical result that serves as a cue for nursing staff to initiate PrI prevention with subsequent successful reduction and sustained decline in FAPrI incidence occurring. This technology's effectiveness has been demonstrated in hospitals; and this study will be the first to extend the use to NHs, a setting that is low in resources and desperate for assistance in this area. An embedded pragmatic stepped wedge clinical trial design will be conducted in 6 NHs within a single NH company with standardized operating procedures and PrI prevention protocols. We will examine whether SEM assessment results reflecting detection of early pressure damage can serve as an effective cue for NH nursing staff initiation of PrI prevention actions with the goal of reducing FAPrI rates over a 8-month intervention period. Specific aims are to:
Aim 1. Determine if early pressure damage detected by SEM assessment at time of visual skin observation of NH resident sacral and heel areas is effective in cueing the initiation of NH standard PrI prevention.
Aim 2. Examine the association between NH standard PrI prevention and SEM assessment and NH residents' characteristics (age, gender, risk, skin tone, race, ethnicity, BMI, Cognitive status) and their interactions on individual NH residents with regard to initiation of PrI prevention and PrI occurrence.
Aim 3. Explore if SEM usability, NH, and nursing staff characteristics influence the adoption and assimilation of early PrI detection and subsequent PrI prevention practices.
Results from this study will increase our knowledge and advance PrI prevention science and nursing practice. Furthermore, the clinical utility and relevance achieved with real world testing and staff delivery will help NHs with high PrI incidence by adding to the clarity of preventive nursing practices. These results will also be used for developing specialty policies and guidelines like the international PrI prevention clinical practice guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- nursing home residents residing at any time in the facility during a 12 month baseline followed by 8 month intervention
| Arm | Type | Receives |
|---|---|---|
| Nursing Home Residents in intervention | Experimental | Device: SEM ScannerAll Nursing Home residents in the facility during the 8 month intervention period |
| Nursing Home Residents in baseline | No intervention | –All Nursing Home residents in the facility during the 12 month baseline period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For intervention, must reside in nursing home at least 1 day during 8-month study period and be at least 18 years old at study start.
- For baseline period: Must reside in nursing home at least 1 day during 52-week lookback period and be at least 18 years old at study start
Key exclusion criteria (1 listed)
- For intervention: Did not reside in nursing home during 8-month study period or younger than 18 years old For baseline period: Did not reside in nursing home during 52-week lookback period or younger than 18 years old
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 |
|---|---|---|
| SEM ScannerAlso: Provizio SEM ScannerImplementation of the SEM Scanner as part of weekly standard skin assessments of sacrum and heels | Device | Nursing Home Residents in intervention |
Primary outcome
New Pressure Injury Prevention Initiated
Time frame: From date of newly identified skin damage through 3 days later, assessed up to 8 months for intervention period or up to 12 months for usual care (Lookback) period
At least one Pressure Injury Prevention action newly initiated defined as electronic health record (EHR) documentation
1 secondary outcome
Time to Pressure Injury Prevention Initiation
Time frame: Number of days from date of identified skin damage through 3 days later, assessed up to 8 months for intervention period or up to 12 months for baseline period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Barbara M Bates-Jensen, PhD principal investigator
Univeristy of California Los Angeles
Tracey L Yap, PhD principal investigator
Duke University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SEM Scanner in people with Pressure Injury, run by University of California, Los Angeles at 7 sites in United States.
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 2 inclusion and 1 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
New Pressure Injury Prevention Initiated (time frame: From date of newly identified skin damage through 3 days later, assessed up to 8 months for intervention period or up to 12 months for usual care (Lookback) period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.