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

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

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

Study Overview

• Status: Recruiting
• Conditions: Preventive Care
• Intervention / Treatment: Diagnostic test: SEM Scanner

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

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Gallien, Doctor; Phone Number: +33299295099; Email: philippe.gallien@pole-Sthellier.com
• Study Contact Backup: Name: Jean-Paul Haeberle; Phone Number: +33626742085; Email: jean-paul.haeberle@arjo.com

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35000
      • Recruiting
      • Pôle Saint-Hélier
      • Principal Investigator: Philippe Gallien, Doctor
      • Contact: Philippe GALLIEN, Doctor; Phone Number: +33299295099; Email: philippe.gallien@pole-sthelier.com
      • Contact: JEAN PAUL HAEBERLE; Phone Number: +33626742085; Email: jean-paul.haeberle@arjo.com
      • Sub-Investigator: Sandrine Robineau, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sample for reliability; 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.	Diagnostic test: SEM 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the reliability of the SEM Scanner on a population in a rehabilitation center (experienced vs experienced)	We will calculate the intra-class correlation coefficient (ICC) intra- and inter-evaluator (experienced vs experienced)	immediately after the intervention
Evaluation of the validity of the SEM Scanner on at risk population	Intra-class correlation coefficient is the correlation coefficient between SEM Scanner measure and the norton scare	immediately after the intervention
Evaluation of the validity of the SEM Scanner on at risk population	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	During the evaluation 1 day assessed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
valuation of the reliability of the SEM Scanner on a population at risk (experienced vs novice/ novice vs novice) will be calculated	The intra-class correlation coefficient (ICC) intra- and inter- evaluator (experienced vs novice/novice vs novice) will be calculated	immediately after the intervention
Receiver Operating Characteristics (ROC)curve: Area under the Curve (AUC)	AUC of the SEM Scanner for every cut of scores of the Norton score	immediately after the intervention

Collaborators and Investigators

• Sponsor: Arjo France
• Collaborators: Pôle Saint Hélier

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: 2021-A00458-33

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No