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

Primary Purpose

Preventive Care

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

SEM Scanner

About this trial

This is an interventional prevention trial for Preventive Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Pole Saint-HélierRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sample for reliability

Arm 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.

Outcomes

Primary Outcome Measures

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)

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

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

Secondary Outcome Measures

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

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

AUC of the SEM Scanner for every cut of scores of the Norton score

Full Information

NCT ID

NCT04955106

First Posted

June 24, 2021

Last Updated

July 22, 2021

Sponsor

Arjo France

Collaborators

Pôle Saint Hélier

1. Study Identification

Unique Protocol Identification Number

NCT04955106

Brief Title

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

Acronym

RELIASEM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 22, 2021 (Actual)

Primary Completion Date

September 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arjo France

Collaborators

Pôle Saint Hélier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preventive Care

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sample for reliability

Arm Type

Other

Arm 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.

Intervention Type

Diagnostic Test

Intervention Name(s)

SEM Scanner

Intervention Description

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

Primary Outcome Measure Information:

Title

Evaluation of the reliability of the SEM Scanner on a population in a rehabilitation center (experienced vs experienced)

Description

We will calculate the intra-class correlation coefficient (ICC) intra- and inter-evaluator (experienced vs experienced)

Time Frame

immediately after the intervention

Title

Evaluation of the validity of the SEM Scanner on at risk population

Description

Intra-class correlation coefficient is the correlation coefficient between SEM Scanner measure and the norton scare

Time Frame

immediately after the intervention

Title

Evaluation of the validity of the SEM Scanner on at risk population

Description

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

Time Frame

During the evaluation 1 day assessed

Secondary Outcome Measure Information:

Title

valuation of the reliability of the SEM Scanner on a population at risk (experienced vs novice/ novice vs novice) will be calculated

Description

The intra-class correlation coefficient (ICC) intra- and inter- evaluator (experienced vs novice/novice vs novice) will be calculated

Time Frame

immediately after the intervention

Title

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

Description

AUC of the SEM Scanner for every cut of scores of the Norton score

Time Frame

immediately after the intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Philippe Gallien, Doctor

Phone

+33299295099

philippe.gallien@pole-Sthellier.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jean-Paul Haeberle

Phone

+33626742085

jean-paul.haeberle@arjo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe Gallien, Doctor

Organizational Affiliation

Pôle Saint Hélier

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pole Saint-Hélier

City

Rennes

State/Province

Bretagne

ZIP/Postal Code

35000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philippe GALLIEN, Doctor

Phone

+33299295099

philippe.gallien@pole-sthelier.com

First Name & Middle Initial & Last Name & Degree

JEAN PAUL HAEBERLE

Phone

+33626742085

jean-paul.haeberle@arjo.com

First Name & Middle Initial & Last Name & Degree

Philippe Gallien, Doctor

First Name & Middle Initial & Last Name & Degree

Sandrine Robineau, Doctor

12. IPD Sharing Statement

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

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