Trial Outcomes & Findings for Evaluation of the SEM Scanner 200 for the Detection of Early Pressure Ulcers: A Multi-Site Longitudinal Study (NCT NCT02701101)

Last Updated: 2020-10-19

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

189 participants

Primary outcome timeframe

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.

Results posted on

2020-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Daily Skin Assessments (Standard of Care and SEM 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
Overall Study STARTED	189
Overall Study COMPLETED	189
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the SEM Scanner 200 for the Detection of Early Pressure Ulcers: A Multi-Site Longitudinal Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daily Skin Assessments (SoC and SEM Scanner Readings) n=182 Participants 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
Age, Customized >55 years of age	182 Participants n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants
Sex: Female, Male Male	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	158 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	44 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	121 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Daily Skin Assessments (SoC and SEM Scanner Readings) n=182 Participants 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.
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 Interval 74.8 to 95.3

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Daily Skin Assessments (SoC and SEM Scanner Readings) n=182 Participants 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.
The Specificity of the SEM Scanner Device (60% or Above) for Detecting Early Pressure Ulcers	32.9 Percentage of True negatives Interval 28.3 to 37.8

SECONDARY outcome

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").

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.

Outcome measures

Outcome measures
Measure	Daily Skin Assessments (SoC and SEM Scanner Readings) n=182 Participants 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.
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

Adverse Events

Daily Skin Assessments (Standard of Care and SEM Readings)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Daily Skin Assessments (Standard of Care and SEM Readings) n=189 participants at risk 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
General disorders Unrelated to device AE	0.53% 1/189 • Number of events 1 • 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. All enrolled 189 subjects were scanned using the SEM scanner and Visual Skin Assessments. AE events could not be distinguished by arm. All SAE's (clinicaltrials.gov definition) and any device related AEs were defined as "SAEs" consistent with the non-significant risk classification/indication for the device. AEs (clinicaltrials.gov definition) and unrelated to the device were defined as AE's. SAE, AE events are reported in enrolled 189 subjects as opposed to ITT analysis for 182.

Additional Information

Vignesh Iyer

Bruin Biometrics

Phone: 3102689494

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Principal Investigator and Institution shall be free to publish and present the results and data from the Study per the following conditions.The manuscript or abstract proposed to be published or presented shall be submitted to Sponsor for review and comment at least forty-five (45) days prior to submission for publication or presentation to allow Sponsor to protect its rights to any patentable inventions disclosed in such publication or presentation.
Publication restrictions are in place

Restriction type: OTHER