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

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ClinicalTrials.gov Identifier: NCT02701101
Recruitment Status : Completed
First Posted : March 8, 2016
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Bruin Biometrics, LLC

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 skin assessments.

Condition or disease Intervention/treatment Phase
Pressure Ulcers Device: Use of SEM200 Scanner daily Other: Assessment and treatment of Pressure Ulcers using SOC Not Applicable

Detailed Description:

Demonstrate that the SEM Scanner can detect early pressure ulcers in patients before pressure ulcers are diagnosed through clinical judgment ("diagnose pressure ulcers before clinical judgment").

Determine the average number of days between detection of early pressure ulcers using the SEM Scanner and diagnosis of pressure ulcers through clinical judgment ("time to detection").


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the SEM Scanner 200 for the Detection of Early Pressure Ulcers: A Multi-Site Longitudinal Study
Study Start Date : April 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Experimental: Use of SEM scanner daily
Use of SEM scanner daily to assess presence or absence of a Pressure Ulcer
Device: Use of SEM200 Scanner daily
From enrollment to exit,daily SEM Scanner readings collected on Sacrum and Heels

Active Comparator: Standard of Care
Use of current gold standard tools for Pressure Ulcer diagnosis Skin and Risk Assessments
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




Primary Outcome Measures :
  1. The sensitivity of the SEM Scanner device (70% or above) for detecting early pressure ulcers before routine skin assessments [ Time Frame: 3-4 months ]
    Observed Daily up to 21 days

  2. The specificity of the SEM Scanner device (60% or above) for detecting early pressure ulcers [ Time Frame: 3-4 months ]
    observed daily up to 21 days



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701101


Locations
United States, Pennsylvania
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Bruin Biometrics, LLC

Responsible Party: Bruin Biometrics, LLC
ClinicalTrials.gov Identifier: NCT02701101     History of Changes
Other Study ID Numbers: SEM200-008
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases