Clinical trial NCT05846152: 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)
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Healing
Keywords: Wound
Healing
Surface
Tissue content
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: WoundCare (AKA WoundTrack) the principal investigator
timeFrame: During the study inclusion visit
measure: Transparent sheet by principal investigator
timeFrame: During the study inclusion visit
Secondary outcomes:
measure: Eye by the principal investigator
timeFrame: During the study inclusion visit
measure: Ruler by the principal investigator
timeFrame: During the study inclusion visit
measure: Eye by the second investigator
timeFrame: During the study inclusion visit
measure: Ruler by the second investigator
timeFrame: During the study inclusion visit
measure: WoundCare (AKA WoundTrack) the second investigator
timeFrame: During the study inclusion visit
measure: Transparent sheet by second investigator
timeFrame: During the study inclusion visit
Other outcomes:
Locations:
Study officials:
affiliation: HAGUENAU Hospital
name: Guillaume Maxant, Dr
role: PRINCIPAL_INVESTIGATOR
References: