Burns, Hypertrophic Scar
Conditions
Brief summary
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).
Interventions
DEVICE3D scan measurment
patients 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.
Sponsors
Centre Hospitalier Régional Metz-Thionville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Patients under guardianship, curatorship or safeguard of justice * Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sucess of the manufacture process of the orthosis | 2 to 3 hours after inclusion | 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
| Measure | Time frame | Description |
|---|---|---|
| Time of conception | 2 to 3 hours after inclusion | Total time to make the orthosis (minutes) |
| Total time to design the orthosis | 2 to 3 hours after inclusion | Total time to design the orthosis (minutes) |
| Total cost of the orthosis fabrication | 2 to 3 hours after inclusion | Total cost of the orthosis fabrication (minutes) |
Countries
France
Contacts
CONTACTAndreia CARVALHO DE FREITAS
PRINCIPAL_INVESTIGATORLoic BANASZAK
CHR Metz Thionville Hopital Félix Maréchal
Outcome results
None listed