Clinical trial NCT02701101: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcers
Keywords: subepidermal moisture
Lead sponsor: Bruin Biometrics, LLC
Sponsor class: INDUSTRY
First posted: 2016-03-08
Enrollment: 189
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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).
Primary purpose: OTHER

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").

Eligibility criteria: 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

Primary outcomes:
measure: The Sensitivity of the SEM Scanner Device (70% or Above) for Detecting Early Pressure Ulcers Before Routine Skin Assessments
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.
measure: The Specificity of the SEM Scanner Device (60% or Above) for Detecting Early Pressure Ulcers
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.
Secondary outcomes:
measure: 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").
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.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson Hospital
state: Pennsylvania
Study officials:
References:
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.