Pressure Ulcers
Conditions
Keywords
subepidermal moisture
Brief 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.
Detailed description
All subjects are followed for a minimum of 6 days to a maximum of 21 days upon enrollment or until exit from the study . Enrolled subjects are assessed once daily throughout the follow-up period. Assessments are performed at the sacrum and both heels; if one or more locations are not assessable with the SEM Scanner, only the assessable locations are assessed. Each study site may include one or two wound care specialist (or a similarly trained clinician; the Specialist) and one or two clinician/patient care provider(s) (the Generalist) who perform assessments in the study. Study assessments include (i) daily Risk Assessment and (ii) daily Skin Assessment performed by the Specialist blinded to the SEM readings; and (iii) daily SEM Scanner readings collected by the Generalist blinded to the Risk and Skin assessments. The outcome of interest is the diagnosis of a pressure ulcer by the Specialist using clinical judgment. The Specialist stages any diagnosed pressure ulcers according to NPUAP/EPUAP 2014 guidelines. Note: If applicable, enrolled subjects continue to receive facility's standard of care practices for pressure ulcer preventive care. Participation in the study does not alter patient's standard of care. This study involved two study objectives - 1. A primary objective to demonstrate the sensitivity and specificity of the SEM Scanner 200 in detecting early pressure ulcers before clinical judgment (diagnose PU before clinical judgment). 2. A secondary objective to determine how early the SEM Scanner can detect signs before visually identified via clinical judgment (time to detection).
Interventions
DEVICEUse of SEM200 Scanner daily
From enrollment to exit,daily SEM Scanner readings collected on Sacrum and Heels
OTHERAssessment and treatment of Pressure Ulcers using SOC
Nurse review of Skin risk and skin assessment, notes in chart to assess the frequency to turn patient, use of a specialist bed to prevent or treat early pressure ulcers
Sponsors
Bruin Biometrics, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
It was essential that both assessing teams' results were blinded to each other. Blinding between the Specialist and the Generalist teams was successfully upheld in this study. Data entry was structured in a manner restricting access based on roles and responsibilities defined in the study. The Study Investigators and Study Coordinators (gate-keeper) were also diligent about ensuring blinding between the two assessing teams. The Principal Investigator or designated Co-Investigator were unblinded to the results of each study subject at the time of eCRF approval or exit for that subject. Prior to interim analysis, BBI's management team were also restricted to access the study's database, and thus were blinded to daily results. This further assures that no bias is introduced by the study sponsor to data collection.
Intervention model description
Enrolled subjects were evaluated once daily throughout the observation period for a minimum of 6 days to a maximum of 21 days upon enrollment or earlier exit from the study. Daily assessments were performed at the sacrum and both heels unless anatomical location(s) were not assessable. As it was unethical to withhold standard of care preventive measures from the enrolled subjects, in addition to the daily data collection of those listed above, daily prevention/intervention measures data was also collected. Prevention/intervention measures implemented may allow the physiology of the tissue to return to normal when intervened upon early in the pressure ulcer development pathway. Daily assessments included: 1. Risk Assessment (standard of care; Braden, Waterlow, or Norton) 2. Skin Assessment (Standard of Care visual skin assessments utilizing tactile and visual cues; and, 3. SEM Scanner readings (test variable in this study).
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Greater or equal to 55 years of age 2. At risk of developing a pressure ulcer at time of enrollment as defined by one or more of the following: 1. PU Risk Score - Braden \< 15; Waterlow ≥ 10; or Norton ≤ 18 2. Poor mobility; e.g., Braden mobility subscore ≤ 2; Waterlow mobility subscore \> 2; Norton mobility subscore ≤ 2; or poor mobility according to clinical judgment (chair- or bed-bound) 3. Poor nutrition; e.g., Braden nutrition subscore ≤ 2; Waterlow nutrition subscore \> 2; or poor nutrition according to clinical judgment 4. Medical procedure (e.g. surgery, x-ray, etc.) involving immobility and inability to change position lasting 4 hours or longer 3. Evaluable by the study team for a minimum of 6 consecutive days upon enrollment 4. Willing and able to provide informed consent (or by proxy)
Exclusion criteria
1. Unhealed (including newly diagnosed) pressure ulcer at any anatomical site at the time of enrollment 2. 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 3. Moisture lesion or incontinence associated dermatitis at the sacrum 4. Physical, structural, or other limitations preventing assessments required in this study (e.g., suspected or actual injury preventing turning) 5. Presence of any condition(s) or injury(ies) which compromises the subject's ability to complete this study 6. Per clinical decision of the study Investigator, diminished decision-making capacity which might impact compliance or completion with study procedures 7. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Sensitivity of the SEM Scanner Device (70% or Above) for Detecting Early Pressure Ulcers Before Routine Skin Assessments | A subject was included in the analysis when they had at least one valid series within 5 days of visual skin assessment identification of a pressure ulcer (6-21 observation days), or study exit when no pressure ulcer was identified. | This study was powered to detect at least 70% sensitivity and 55% specificity of the device compared to the reference standard of clinical STA, with 95% confidence. A total of 189 patients were enrolled, of which 96.3% (n = 182) patients were listed as intent-to-treat (ITT). |
| The Specificity of the SEM Scanner Device (60% or Above) for Detecting Early Pressure Ulcers | A subject was included in the analysis when they had at least one valid series within 5 days of visual skin assessment identification of a pressure ulcer (6-21 observation days), or study exit when no pressure ulcer was identified. | The use of specificity as an end point was recognized, before study inception, as a worst-case assessment for the SEM test because it classes all results in which a pressure ulcer did not visibly manifest (STA negative) but where changes in SEM were observed (SEM positive) as false positive results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | A subject was included in the analysis when they had at least one valid series within 5 days of visual skin assessment identification of a pressure ulcer (6-21 observation days), or study exit when no pressure ulcer was identified. | The measure for secondary endpoint is the Number of Days between pressure ulcer diagnosis by clinical judgment of the Specialist and the first day of SEM Scanner delta \>0.5 (time to detection). For the secondary endpoint, the first measurement of the Valid Series can be at any time during the subject's participation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Daily Skin Assessments (SoC and SEM Scanner Readings) The SEM Scanner 200 measures sub-epidermal moisture (SEM), which has been studied as an indicator of localized edema characteristic of pressure-induced tissue damage. Daily assessments were performed at the sacrum and both heels unless the anatomical location(s) were not assessable. Daily assessments included:
1. Risk Assessment (standard of care; Braden, Waterlow, or Norton)
2. Skin Assessment (standard of care visual skin assessments utilizing tactile and visual cues)
3. SEM Scanner readings (test variable in this study). Standard of care evaluations were conducted by individuals meeting the definition of Specialist specified in the study protocol whereas separate individuals meeting the definition of Generalist performed SEM Scanner 200 measurements. Specialists were blinded to the assessment by the Generalists, and vice versa
Use of SEM200 Scanner daily: From enrollment to exit,daily SEM Scanner readings collected on Sacrum and Heels
Assessment and treatment o | 182 |
| Total | 182 |
Baseline characteristics
| Characteristic | Daily Skin Assessments (SoC and SEM Scanner Readings) |
|---|---|
| Age, Customized >55 years of age | 182 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 158 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 44 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 121 Participants |
| Sex: Female, Male Female | 97 Participants |
| Sex: Female, Male Male | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 189 |
| other Total, other adverse events | 1 / 189 |
| serious Total, serious adverse events | 0 / 189 |
Outcome results
Primary
The Sensitivity of the SEM Scanner Device (70% or Above) for Detecting Early Pressure Ulcers Before Routine Skin Assessments
This study was powered to detect at least 70% sensitivity and 55% specificity of the device compared to the reference standard of clinical STA, with 95% confidence. A total of 189 patients were enrolled, of which 96.3% (n = 182) patients were listed as intent-to-treat (ITT).
Time frame: A subject was included in the analysis when they had at least one valid series within 5 days of visual skin assessment identification of a pressure ulcer (6-21 observation days), or study exit when no pressure ulcer was identified.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daily Skin Assessments (SoC and SEM Scanner Readings) | 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 |
Primary
The Specificity of the SEM Scanner Device (60% or Above) for Detecting Early Pressure Ulcers
The use of specificity as an end point was recognized, before study inception, as a worst-case assessment for the SEM test because it classes all results in which a pressure ulcer did not visibly manifest (STA negative) but where changes in SEM were observed (SEM positive) as false positive results.
Time frame: A subject was included in the analysis when they had at least one valid series within 5 days of visual skin assessment identification of a pressure ulcer (6-21 observation days), or study exit when no pressure ulcer was identified.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daily Skin Assessments (SoC and SEM Scanner Readings) | The Specificity of the SEM Scanner Device (60% or Above) for Detecting Early Pressure Ulcers | 32.9 Percentage of True negatives |
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).
The measure for secondary endpoint is the Number of Days between pressure ulcer diagnosis by clinical judgment of the Specialist and the first day of SEM Scanner delta \>0.5 (time to detection). For the secondary endpoint, the first measurement of the Valid Series can be at any time during the subject's participation.
Time frame: A subject was included in the analysis when they had at least one valid series within 5 days of visual skin assessment identification of a pressure ulcer (6-21 observation days), or study exit when no pressure ulcer was identified.
Population: Secondary endpoint is only analyzed for subjects identified with positive detection (pressure ulcer by Specialist and SEM Scanner with delta \>0.5).The Number of Days is the difference between pressure ulcer diagnosis by clinical judgment of the Specialist and the first day of SEM Scanner delta \>0.5 (time to detection).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daily Skin Assessments (SoC and SEM Scanner Readings) | 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 days | Standard Deviation 2.39 |