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

Completed · Not applicable

Conditions studied: Pressure Ulcers

In brief

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.

Key facts

Study ID

NCT02701101

Run by

Bruin Biometrics, LLC

People needed

189

Starts

2016-04-01

Expected to finish

2017-03-01

Last updated by the study team

2020-10-19

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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
• 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

Where it is running

• Thomas Jefferson Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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