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

NCT02701101 | Completed Results

• 1 other identifier: SEM200-008
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcers

Keywords

subepidermal moisture

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• 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.

Study Arms (1)

Daily Skin Assessments (SoC and SEM Scanner Readings)

OTHER

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.

Device: Use of SEM200 Scanner daily; Other: Assessment and treatment of Pressure Ulcers using SOC

Interventions

Use of SEM200 Scanner daily DEVICE

From enrollment to exit,daily SEM Scanner readings collected on Sacrum and Heels

Daily Skin Assessments (SoC and SEM Scanner Readings)

Assessment and treatment of Pressure Ulcers using SOC OTHER

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

Daily Skin Assessments (SoC and SEM Scanner Readings)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Unhealed (including newly diagnosed) pressure ulcer at any anatomical site at the time of enrollment
• 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

Sponsors & Collaborators

• Bruin Biometrics, LLC: lead

Study Sites (1)

Thomas Jefferson Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related 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. Wound Repair Regen. 2020 May;28(3):364-374. doi: 10.1111/wrr.12790. Epub 2020 Jan 21.

  PMID: 31965682 RESULT

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Results Point of Contact

• Title: Vignesh Iyer
• Organization: Bruin Biometrics

viyer@bruinbiometrics.com

3102689494

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: March 8, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: March 1, 2017
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)