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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01965444

Enrollment

Registered

2013-10-18

Start date

2013-09-30

Completion date

2013-10-31

Last updated

2013-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcers

Keywords

Sub-epidermal moisture, Pressure Ulcers

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results