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

Pressure Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701101
• Other study ID #: SEM200-008
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: March 2017

Study information

• Verified date: September 2020
• Source: Bruin Biometrics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: March 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Ulcer

Intervention

Device:
• Use of SEM200 Scanner daily
From enrollment to exit,daily SEM Scanner readings collected on Sacrum and Heels

Other:
• Assessment 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

Locations

Country	Name	City	State
United States	Thomas Jefferson Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bruin Biometrics, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	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.
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.	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	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.	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.

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