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Skin Change Actions by Nursing

NCT06127524 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4733

Last updated 2026-01-12

No results posted yet for this study

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.

Conditions

  • Pressure Injury

Interventions

DEVICE

SEM Scanner

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

Sponsors & Collaborators

Principal Investigators

  • Barbara M Bates-Jensen, PhD · Univeristy of California Los Angeles

  • Tracey L Yap, PhD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2025-02-22
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06127524 on ClinicalTrials.gov