Brief 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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

4,733

participants targeted

Target at P75+ for phase_2

Timeline

1mo left

Started Dec 2023

Geographic Reach

1 country

7 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.6 years study duration

Study Progress94%

Dec 2023Jun 2026

First Submitted

Initial submission to the registry

October 19, 2023

Completed

25 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed

21 days until next milestone

Study Start

First participant enrolled

December 4, 2023

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2025

Completed

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

October 19, 2023

Last Update Submit

January 9, 2026

Conditions

Pressure Injury

Keywords

Nursing homestechnology implementationsub epidermal moisture

Outcome Measures

Primary Outcomes (1)

New pressure injury prevention initiated
At least one Pressure Injury Prevention action newly initiated defined as electronic health record (EHR) documentation
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

Secondary Outcomes (1)

Time to pressure injury prevention initiation
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

Other Outcomes (2)

Sacral and/or heel pressure injury occurrence
From at least 3 weeks since prior pressure injury occurrence (if ever), assessed up to 8 months for intervention period or up to 12 months for baseline period
Time to pressure injury occurrence
Number of days from date of new pressure injury occurrence (from at least 3 weeks since prior pressure injury, if ever), assessed up to 8 months for intervention period or up to 12 months for baseline period

Study Arms (2)

Nursing Home Residents in intervention

EXPERIMENTAL

All Nursing Home residents in the facility during the 8 month intervention period

Device: SEM Scanner

Nursing Home Residents in baseline

NO INTERVENTION

All Nursing Home residents in the facility during the 12 month baseline period

Interventions

SEM ScannerDEVICE

Implementation of the SEM Scanner as part of weekly standard skin assessments of sacrum and heels

Also known as: Provizio SEM Scanner

Nursing Home Residents in intervention

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.