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NCT06127524 · ClinicalTrials.gov registry record · Phase 2
Skin Change Actions by Nursing
A Phase 2 study of Pressure Injury, sponsored by University of California, Los Angeles.
- Active
- Registry status
- Phase 2
- Development phase
- 4,733
- Enrollment target
- 7
- Study locations
NCT06127524: Active Phase 2 study of Pressure Injury, sponsored by University of California, Los Angeles.
NCT06127524 is a Phase 2 study of Pressure Injury that is active but no longer recruiting, run by University of California, Los Angeles. The registered enrollment target is 4,733 participants, above the 377-participant average among 6 other Pressure Injury trials with a reported enrollment target (1155% higher). The trial reports 7 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06127524, a Phase 2 study of Pressure Injury, is active but no longer recruiting, sponsored by University of California, Los Angeles.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 4,733 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
At least one Pressure Injury Prevention action newly initiated defined as electronic health record (EHR) documentation
Conditions Studied
Interventions
- DEVICE SEM Scanner
Study Locations (7)
Pennsylvania
- Large proprietary nursing home chain faciity #3 - Kennett Square
- Large proprietary nursing home chain facility #1 - Kennett Square
- Large proprietary nursing home chain facility #4 - Kennett Square
- Large proprietary nursing home chain facility #5 - Kennett Square
- Large proprietary nursing home chain facility #6 - Kennett Square
- Large proprietary nursing home chain facility #7 - Kennett Square
- Large proprietary nursing home chain facilty #2 - Kennett Square
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,733 participants |
| Start Date | 2023-12-04 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What the registry record for NCT06127524 still lists
NCT06127524 is an interventional study that assigns participants to a tested intervention. Its 4,733 participants enrollment target places it among the larger protocols in the corpus, above the 377-participant average among 6 other Pressure Injury trials with a reported enrollment target (1155% higher).
The record links to 1 condition, with Pressure Injury appearing as the primary indexed condition, and to 1 intervention - of which SEM Scanner is the first listed.
NCT06127524 lists 7 locations in 1 state (Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT06127524 about?
NCT06127524 is a clinical study titled "Skin Change Actions by Nursing". 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 i...
What is the current status of trial NCT06127524?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 4,733 participants. The study started on 2023-12-04. Estimated completion is 2026-06-30.
What conditions does trial NCT06127524 study?
This clinical trial studies the following conditions: Pressure Injury.
What interventions are being tested in trial NCT06127524?
The interventions under investigation include: SEM Scanner (DEVICE).
Who is sponsoring clinical trial NCT06127524?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06127524 being conducted?
This trial has 7 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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