A Test of the Investigational SEM Scanner

An Investigational, Non-significant Risk Study to Collect Data Needed to Analyze Readings Given by the SEM Scanner Point of Care 200 Series (SEM POC 200) and Its Ability to Detect Sub Epidermal Moisture.

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcers

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMASS Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Intensive Care Units

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bruin Biometrics, LLC
• Investigators: Principal Investigator: Timothy Emhoff, MD, UMASS Memorial Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: October 16, 2013
• First Submitted That Met QC Criteria: October 16, 2013
• First Posted (Estimate): October 18, 2013

Study Record Updates

• Last Update Posted (Estimate): December 24, 2013
• Last Update Submitted That Met QC Criteria: December 23, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Pressure Ulcers; Sub-epidermal moisture
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: SEM200-001