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) (PIXAIRE_I)

Central Hospital, Nancy, France

Status

Not yet enrolling

Conditions

Wound Healing

Treatments

Device: Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05846152

2022-A01546-37

Details and patient eligibility

About

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

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.