Study of the Concordance of the Measurements Between the Evaluation of the Area of a Wound by the Technique of Transparent (Gold Standard) Compared to the Evaluation of the Area by the Algorithm of a Decision Support System (Wound-size)

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the evaluation of a wound area and wound tissue content made by different methods on patient population with need for directed wound healing. The main question test of the concordance of the measurements between the evaluation of the area of a wound by the technique of transparent (Gold standard) compared to the evaluation of the area by the algorithm of a decision support system (WoundSize) Patient wounds will be examined: by eye by the principal investigator using a ruler by the principal investigator by WoundCare algorithms (AKA WoundTrack) using smartphone photography by the principal investigator tracing the outline of the wound using a transparent sheet by the principal investigator by eye by a second investigator using a ruler by a second investigator by WoundCare (AKA WoundTrack) algorithms using smartphone photography by a second investigator. tracing the outline of the wound using a transparent sheet by the second investigator

Official Title
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Study of the Concordance of the Measurements Between the Evaluation of the Area of a Wound by the Technique of Transparent (Gold Standard) Compared to the Evaluation of the Area by the Algorithm of a Decision Support System (Wound-size)

Conditions
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Wound Healing

Intervention / Treatment
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* Device: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient suffering from a wound requiring controlled healing ranging from 4 to 150 cm² Age greater than or equal to 18 years old Person affiliated to a social security scheme or beneficiary of such a scheme Person having received complete information on the organization of the research and having signed informed consent. Wound that can be taken in one photo in its entirety. Exclusion Criteria: Person with a medical condition which, in the judgment of the investigator, is not compatible with participation in the study Wound on a part of the body that would make the person participating in the photos of the wound identifiable (tattoo, piercing, birthmark, etc.). Several wounds are in the photo. Pregnant, parturient or breastfeeding women Person deprived of liberty by a judicial or administrative decision Adult subject to a measure of legal protection (guardianship, curatorship, safeguard of justice) or unable to express their consent, persons subject to psychiatric care.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WoundCare medical device<br>Unique arm. The patients undergo all interventions planned in the study. | Device: Intervention<br>* Patient wounds will be examined: by eye by the principal investigator using a ruler by the principal investigator by WoundCare algorithms (AKA WoundTrack) using smartphone photography by the principal investigator by eye by a second investigator using a ruler by a second investigator by WoundCare (AKA WoundTrack) algorithms using smartphone photography by a second investigator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WoundCare (AKA WoundTrack) the principal investigator | Surface (cm2) is evaluated using the software WoundCare (AKA WoundTrack) the principal investigator | During the study inclusion visit | 
| Transparent sheet by principal investigator | Surface (cm2) is evaluated tracing the outline of the wound using a transparent sheet by the principal investigator | During the study inclusion visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye by the principal investigator | Surface (cm2) is evaluated by the eye of the principal investigator | During the study inclusion visit | 
| Ruler by the principal investigator | Surface (cm2) is evaluated using a ruler by the principal investigator | During the study inclusion visit | 
| Eye by the second investigator | Surface (cm2) is evaluated by the eye of the second investigator | During the study inclusion visit | 
| Ruler by the second investigator | Surface (cm2) is evaluated using a ruler by the second investigator | During the study inclusion visit | 
| WoundCare (AKA WoundTrack) the second investigator | Surface (cm2) is evaluated using the software WoundCare (AKA WoundTrack) the second investigator | During the study inclusion visit | 
| Transparent sheet by second investigator | Surface (cm2) is evaluated tracing the outline of the wound using a transparent sheet by the second investigator | During the study inclusion visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound, Healing, Surface, Tissue content