Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04955106
Other study ID # 2021-A00458-33
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT02915653 - Adult Primary and Preventive Practice (APPP) Study N/A
Completed NCT00581347 - Primary Care and Adolescent Immunization for Rochester N/A
Completed NCT04847856 - Diabetic Self-care Education at Primary Health Care in Saudi Arabia: A Pragmatic Randomized Trial in Tabuk N/A
Completed NCT03091036 - Impact of a Health Intervention on Some Indicators in the Care of Chronic Complex Patient (CCP). N/A
Completed NCT01188629 - Conversational IT for Better, Safer Pediatric Primary Care Phase 2
Completed NCT06184386 - Oral Feeding Delay Prevention in Preterm Newborns