Evaluation of the Sub Epidermal Moisture a Device for the Screening of Pressure Ulcer (RELIASEM)
- Conditions
- Preventive Care
- Interventions
- Diagnostic Test: SEM Scanner
- Registration Number
- NCT04955106
- Lead Sponsor
- Arjo France
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 52
- 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),
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sample for reliability SEM Scanner Reliability and validity of SEM Scanner : intra rater, inter rater and inter novice/trained 8(2 trained rater, 2 novice rater, each one performed twice)measured will be performed on each patient.
- Primary Outcome Measures
Name Time Method Evaluation of the validity of the SEM Scanner on at risk population During the evaluation 1 day assessed The Norton scale will be used by the study :Norton ≥ 18 low or without risk, 14\< Norton \<18 medium risk, 12≤ Norton ≤14 high risk, Norton \< 12 very high risk
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)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pole Saint-Hélier
🇫🇷Rennes, Bretagne, France