About this trial
This is a pilot, single-center, feasibility study to evaluate a new 3D printing method for ORDP design.
To our knowledge, there is no technical or clinical evaluation of ORDPs, particularly in the treatment of hypertrophic scars. The aim of our study is therefore to assess the feasibility of an innovative method of designing ORDPs for the curative treatment of post-burn hypertrophic scars, using a 3D printing process, and to describe the procedures (production time and cost).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult Patients aged > 18 years old
Patient with at least one hypertrophic burn scar in the process of healing localized on a skin area that can benefit from a compression garment and requiring the use of an ORDP
Patient able to give informed consent
Patient affiliated to a social security scheme
Disqualifiers
Patients under guardianship, curatorship or safeguard of justice
Pregnant or breast-feeding women
Trial design
Single group
Treatments tested in this trial
3D scan measurment
Devicepatients included in the study will undergo a 3D scan measurement of on or more burn scars. This measurement will then be digitally modified in preparation for the manufacture of the "differential pressure distribution orthosis". The orthosis will then be manufactured using a 3D printing process.
Treatment groups
Trial outcomes
Primary outcomes
Sucess of the manufacture process of the orthosis
Defined as the compliance with all three of the following specifications: 1) oval shapes are approximately 2 mm thick, 2) absence of wounding areas (prickly or sharp), 3) a satisfactory morphological match with the area to be treated.
Secondary outcomes
Time of conception
Total time to make the orthosis (minutes)
Total time to design the orthosis
Total time to design the orthosis (minutes)
Total cost of the orthosis fabrication
Total cost of the orthosis fabrication (minutes)
Sponsors and contacts
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