A Test of the Investigational SEM Scanner

Completed

• Conditions: Pressure Ulcers

• Registration Number: NCT01965444
• Lead Sponsor: Bruin Biometrics, LLC

Brief Summary

The objective of this study is to establish required data for SEM Scanner analysis of the readings given by the SEM Scanner in the target patient population.. In order to better understand the data this non-invasive scanner provides a collection of data/readings is required to be collected in a certain population. This will help with clinical interpretation of the numbers and readings this device will provide.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-10-16
• Study First Posted: 2013-10-18
• Last Update Submitted: 2013-12-23
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Subjects are 18 years of age or older.
• Subject or health care proxy is willing and able to provide informed consent for enrollment.
• Subject is agreeable to having skin assessments, blanchability tests, and SEM Scanner readings performed daily at all anatomical sites for a duration of five (5) days, with photography as needed.
• Subject is admitted to an intensive Care Unit (ICU) and has an anticipated ICU course of 48 hours or greater.
• Subject is not Comfort Measures Only (CMO).
• Subject is anticipated to be bedridden for ore than 6 hours per day.
• All four (4) of the subject's anatomical sites in question (sternum, sacrum, left heel and right heel) are accessible for scanning (e.g., no cast or medical device present such that heels are not accessible).

Exclusion Criteria

• Subject has broken skin or scar tissue at the sternum, sacrum, left heel or right heel.
• Subjects for whom the physical act of performing the inspections and measurements required in this study are contra-indicated, as determined by the principal investigator or attending physician.
• Subjects or legal representatives who are unable to understand the aims and objectives of the trial.
• Presence of any condition(s) which seriously compromise(s) the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
• Subject is pregnant.
• Subject is incarcerated.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Descriptive statistic measurements	5 day study period	The endpoint for this study is the establishment of descriptive statistics around readings given by the SEM Scanner.

Trial Locations

Locations (1)

UMass Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States