Clinical trial NCT04955106: Evaluation of the Sub Epidermal Moisture a Device for the Screening of Pressure Ulcer (RELIASEM)
Official title: Evaluation of the Relability and Validity of Device for the Screening of Early Pressure Ulcer in Hospitalization High-risk Patient, the Sub Epidermal Moisture During a Monocebtric Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preventive Care
Lead sponsor: Arjo France
Sponsor class: INDUSTRY
Collaborators: name: Pôle Saint Hélier
First posted: 2021-07-08
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The SEM Scanner is placed on three skin areas (left heel, right heel and sacrum). It measures the moisture of the subcutaneous tissues. If returns a figure wich induces a classification

* negative = value \<0.6 no risk, the figure is displayed in green
* positive = value ≥0.6 proven risk, the figure is displayed in orange

For each patient 3 measurements will be performed. Two of them will have been trained in the use of the SEM Scanner, whereas the others will be novice
Primary purpose: PREVENTION

Brief 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the reliability of the SEM Scanner on a population in a rehabilitation center (experienced vs experienced)
timeFrame: immediately after the intervention
measure: Evaluation of the validity of the SEM Scanner on at risk population
timeFrame: immediately after the intervention
measure: Evaluation of the validity of the SEM Scanner on at risk population
timeFrame: During the evaluation 1 day assessed
Secondary outcomes:
measure: valuation of the reliability of the SEM Scanner on a population at risk (experienced vs novice/ novice vs novice) will be calculated
timeFrame: immediately after the intervention
measure: Receiver Operating Characteristics (ROC)curve: Area under the Curve (AUC)
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pole Saint-Hélier
state: Bretagne
Study officials:
affiliation: Pôle Saint Hélier
name: Philippe Gallien, Doctor
role: PRINCIPAL_INVESTIGATOR
References: