N/A
N=189
Evaluation of the SEM Scanner 200 for the Detection of Early Pressure Ulcers: A Multi-Site Longitudinal Study
Pressure Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT02701101 ↗Enrolled (actual)
189
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: The Sensitivity of the SEM Scanner Device (70% or Above) for Detecting Early Pressure Ulcers Before Routine Skin Assessments — 87.5 percentage of true positives
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Use of SEM200 Scanner daily (Device); Assessment and treatment of Pressure Ulcers using SOC (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Bruin Biometrics, LLC
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Sensitivity of the SEM Scanner Device (70% or Above) for Detecting Early Pressure Ulcers Before Routine Skin Assessments |
87.5 | — |
| PRIMARY The Specificity of the SEM Scanner Device (60% or Above) for Detecting Early Pressure Ulcers |
32.9 | — |
| SECONDARY Determine the Average Number of Days Between Detection of Early Pressure Ulcers Using the SEM Scanner and Diagnosis of Pressure Ulcers Through Clinical Judgement ("Time to Detection"). |
4.74 | — |
Summary
This is a multi-site, longitudinal study to evaluate the use of the SEM Scanner as an adjunct to clinical judgment for detection of early pressure ulcers in patients before clinical judgment using signs of pressure ulcers from skin assessments. longitudinal study to evaluate the use of the SEM Scanner as an adjunct to clinical judgment for detection of early pressure ulcers in patients before skin assessments.
Eligibility Criteria
Inclusion Criteria
- Greater or equal to 55 years of age
- At risk of developing a pressure ulcer at time of enrollment as defined by one or more of the following:
- PU Risk Score - Braden 2; Norton mobility subscore ≤ 2; or poor mobility according to clinical judgment (chair- or bed-bound)
- Poor nutrition; e.g., Braden nutrition subscore ≤ 2; Waterlow nutrition subscore > 2; or poor nutrition according to clinical judgment
- Medical procedure (e.g. surgery, x-ray, etc.) involving immobility and inability to change position lasting 4 hours or longer
- Evaluable by the study team for a minimum of 6 consecutive days upon enrollment
- Willing and able to provide informed consent (or by proxy)
Exclusion Criteria
- Unhealed (including newly diagnosed) pressure ulcer at any anatomical site at the time of enrollment
- Broken skin at the sacrum and both heels that prevents collection of SEM Scanner readings from all three anatomical locations; possible assessment at only one or two locations is not grounds for exclusion
- Moisture lesion or incontinence associated dermatitis at the sacrum
- Physical, structural, or other limitations preventing assessments required in this study (e.g., suspected or actual injury preventing turning)
- Presence of any condition(s) or injury(ies) which compromises the subject's ability to complete this study
- Per clinical decision of the study Investigator, diminished decision-making capacity which might impact compliance or completion with study procedures
- Patient modesty concerns on the part of the subject (or their proxy) that might impact collection of SEM Scanner readings at the anatomical location (heels and sacrum) to be assessed
Data sourced from ClinicalTrials.gov (NCT02701101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.