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Nursing Home Residents in intervention for Pressure Ulcer (SCAN Trial)

Phase 2
Recruiting
Led By Barbara M Bates-Jensen, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

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.

Eligible Conditions
  • Pressure Ulcer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
New pressure injury prevention initiated
Secondary study objectives
Time to pressure injury prevention initiation
Other study objectives
Sacral and/or heel pressure injury occurrence
Time to pressure injury occurrence

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Nursing Home Residents in interventionExperimental Treatment1 Intervention
All Nursing Home residents in the facility during the 8 month intervention period
Group II: Nursing Home Residents in baselineActive Control1 Intervention
All Nursing Home residents in the facility during the 12 month baseline period

Find a Location

Who is running the clinical trial?

East Carolina UniversityOTHER
108 Previous Clinical Trials
37,347 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,554 Previous Clinical Trials
10,262,546 Total Patients Enrolled
1 Trials studying Pressure Ulcer
107 Patients Enrolled for Pressure Ulcer
National Institute of Nursing Research (NINR)NIH
598 Previous Clinical Trials
10,376,594 Total Patients Enrolled
3 Trials studying Pressure Ulcer
3,345 Patients Enrolled for Pressure Ulcer
~1045 spots leftby Jun 2026