Evaluation of the Sub Epidermal Moisture a Device for the Screening of Pressure Ulcer (RELIASEM)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    52
  • sponsor
    Arjo France
Updated on 31 July 2021

Summary

The device that is the subject of this investigation is a diagnostic tool to detect the among of fluid in hypodermis to help to prevent the formation of pressure injuries. The Sub Epidermal Moister(SEM) Scanner, is a non invasive portable medical device use to complet the clinical jugement of clinician

Description

The device that is the subject of this investigation is a diagnostic tool to detect the among of fluid in hypodermis to help to prevent the formation of pressure injuries. The Sub Epidermal Moister(SEM) Scanner, is a non invasive portable medical device use to complet the clinical jugement of clinician.

The study "RELIASEM" will study hospitalized patients with high risk of Pressure Injurieswith the next conditions:

For each patient 14 mesures: 6 on the sacrum, 4 on the right heel and 4 on the left heel. This set of measure will be realized 2 timesby 4 different evaluator. To will have been trained in the use of the SEM Scanner where as the other will be novice.

The main objective of this study is to determine on a risk population the intra- and inter-examiner reliability of the SEM Scanner

Details
Condition Preventive Care
Treatment SEM Scanner
Clinical Study IdentifierNCT04955106
SponsorArjo France
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged over 18
Taken the full-hospital care in physical and rehabilitation Medicine
Patient affiliated with a social security scheme
In the case of curatorship, patient have read the patient information document and given his consent free and informed, in the presence of his/her curator
In the case of guardianship, legal representative have to had read the legal representative information document for major placed under legal protection (under guardianship) and given his consent free and informed for the person for whom he is responsible (if the patient is agree)

Exclusion Criteria

Patient who objected his opposition during the exam
Patient who have one or more presure ulcer on at list one of the measuring area
Patient who has had a lower limb amputation
Pregnant, post natal period or breastfeeding women
Person deprived of liberty by judicial or administrative decision
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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