NCT02701101

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Bruin Biometrics, LLC · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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").

Conditions

• Pressure Ulcers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-11-01
• Completion: 2017-03-01
• First posted: 2016-03-08
• Last updated: 2020-10-19
• Results posted: 2020-10-19

Locations

1 site across 1 country: United States