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

Preventive Care Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04955106
• Other study ID #: 2021-A00458-33
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: December 2021

Study information

• Verified date: July 2021
• Source: Arjo France
• Contact: Philippe Gallien, Doctor
• Phone: +33299295099
• Email: philippe.gallien[@]pole-Sthellier.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Preventive Care

Intervention

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

Locations

Country	Name	City	State
France	Pole Saint-Hélier	Rennes	Bretagne

Sponsors (2)

Lead Sponsor	Collaborator
Arjo France	Pôle Saint Hélier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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