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

NCT02701101 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2020-10-19

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Bruin Biometrics, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-11-30
Completion
2017-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02701101 on ClinicalTrials.gov