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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT06127524
Study groupRoleWhat they receive
Nursing Home Residents in interventionExperimentalAll Nursing Home residents in the facility during the 8 month intervention period
Receives: Device: SEM Scanner
Nursing Home Residents in baselineNo interventionAll 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.

  1. 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)
  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.

  1. First posted13 Nov 2023
  2. Study start4 Dec 2022
  3. Primary completion22 Feb 2025
  4. Study completion30 Jun 2026

Resources

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)
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
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

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