Back to resultsEvaluation of the SEM Scanner 200 for the Detection of Early Pressure Ulcers: A Multi-Site Longitudinal Study
Primary Purpose
Pressure Ulcers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of SEM200 Scanner daily
Assessment and treatment of Pressure Ulcers using SOC
Sponsored by
About this trial
This is an interventional other trial for Pressure Ulcers focused on measuring subepidermal moisture
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 < 15; Waterlow ≥ 10; or Norton ≤ 18
- 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)
- 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
Sites / Locations
- Thomas Jefferson Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Daily Skin Assessments (SoC and SEM Scanner Readings)
Arm Description
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: Risk Assessment (standard of care; Braden, Waterlow, or Norton) Skin Assessment (standard of care visual skin assessments utilizing tactile and visual cues) 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.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02701101
First Posted
February 11, 2016
Last Updated
September 24, 2020
Sponsor
Bruin Biometrics, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02701101
Brief Title
Evaluation of the SEM Scanner 200 for the Detection of Early Pressure Ulcers: A Multi-Site Longitudinal Study
Official Title
Evaluation of the SEM Scanner 200 for the Detection of Early Pressure Ulcers: A Multi-Site Longitudinal Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bruin Biometrics, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 -
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").
A secondary objective to determine how early the SEM Scanner can detect signs before visually identified via clinical judgment ("time to detection").
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
Keywords
subepidermal moisture
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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).
Masking
Care ProviderOutcomes 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.
Allocation
N/A
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daily Skin Assessments (SoC and SEM Scanner Readings)
Arm Type
Other
Arm Description
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:
Risk Assessment (standard of care; Braden, Waterlow, or Norton)
Skin Assessment (standard of care visual skin assessments utilizing tactile and visual cues)
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.
Intervention Type
Device
Intervention Name(s)
Use of SEM200 Scanner daily
Intervention Description
From enrollment to exit,daily SEM Scanner readings collected on Sacrum and Heels
Intervention Type
Other
Intervention Name(s)
Assessment and treatment of Pressure Ulcers using SOC
Intervention Description
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
Primary Outcome Measure Information:
Title
The Sensitivity of the SEM Scanner Device (70% or Above) for Detecting Early Pressure Ulcers Before Routine Skin Assessments
Description
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.
Title
The Specificity of the SEM Scanner Device (60% or Above) for Detecting Early Pressure Ulcers
Description
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.
Secondary Outcome Measure Information:
Title
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").
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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 < 15; Waterlow ≥ 10; or Norton ≤ 18
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)
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
Facility Information:
Facility Name
Thomas Jefferson Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31965682
Citation
Okonkwo H, Bryant R, Milne J, Molyneaux D, Sanders J, Cunningham G, Brangman S, Eardley W, Chan GK, Mayer B, Waldo M, Ju B. A blinded clinical study using a subepidermal moisture biocapacitance measurement device for early detection of pressure injuries. Wound Repair Regen. 2020 May;28(3):364-374. doi: 10.1111/wrr.12790. Epub 2020 Jan 21.
Results Reference
result
Learn more about this trial
Evaluation of the SEM Scanner 200 for the Detection of Early Pressure Ulcers: A Multi-Site Longitudinal Study
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