A Test of the Investigational SEM Scanner
| Status: | Recruiting |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Gastrointestinal |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/30/2013 |
| Start Date: | September 2013 |
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.
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.
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