Preventive Care
Conditions
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
Interventions
DIAGNOSTIC_TESTSEM Scanner
They will perform 2 sets of 3 measures (1 on sacrum, 1 on the right heel and 1 on the left heel)for each patients
Sponsors
Pôle Saint Hélier
Arjo France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the reliability of the SEM Scanner on a population in a rehabilitation center (experienced vs experienced) | immediately after the intervention | We will calculate the intra-class correlation coefficient (ICC) intra- and inter-evaluator (experienced vs experienced) |
| Evaluation of the validity of the SEM Scanner on at risk population | immediately after the intervention | Intra-class correlation coefficient is the correlation coefficient between SEM Scanner measure and the norton scare |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| valuation of the reliability of the SEM Scanner on a population at risk (experienced vs novice/ novice vs novice) will be calculated | immediately after the intervention | The intra-class correlation coefficient (ICC) intra- and inter- evaluator (experienced vs novice/novice vs novice) will be calculated |
| Receiver Operating Characteristics (ROC)curve: Area under the Curve (AUC) | immediately after the intervention | AUC of the SEM Scanner for every cut of scores of the Norton score |
Countries
France
Contacts
Primary ContactPhilippe Gallien, Doctor
Backup ContactJean-Paul Haeberle
Outcome results
None listed