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

NCT04955106 | Unknown

• 1 other identifier: 2021-A00458-33
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Preventive Care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

• Receiver Operating Characteristics (ROC)curve: Area under the Curve (AUC)

  immediately after the intervention

Study Arms (1)

Sample for reliability

OTHER

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

Interventions

SEM Scanner DIAGNOSTIC_TEST

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

Sample for reliability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• 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

Sponsors & Collaborators

• Arjo France: lead
• Pôle Saint Hélier: collaborator

Study Sites (1)

Pole Saint-Hélier

Rennes, Brittany Region, 35000, France

RECRUITING

Study Officials

• Philippe Gallien, Doctor

  Pôle Saint Hélier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Gallien, Doctor

CONTACT

+33299295099; philippe.gallien@pole-Sthellier.com

Jean-Paul Haeberle

CONTACT

+33626742085; jean-paul.haeberle@arjo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 8, 2021
• Study Start: June 22, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

FR (1)