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

Arjo

Status: Unknown

Conditions: Preventive Care

Treatments: Diagnostic Test: SEM Scanner

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04955106

2021-A00458-33

Details and patient eligibility

About

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

Full 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

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

52 participants in 1 patient group

Sample for reliability

Other group

Description:

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.

Treatment:

Diagnostic Test: SEM Scanner