RecruitingNot ApplicableNCT06487910

Differential Pressure Distribution Orthosis by 3D Printing Process in the Treatment of Post-burn Hypertrophic Scarring

Pilot Study on the Design of a 3D-printed Differential Pressure Distribution Orthosis for the Treatment of Post-burn Hypertrophic Scarring

Sponsor

Centre Hospitalier Régional Metz-Thionville

Enrollment

25 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

Burns

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria2

Patients under guardianship, curatorship or safeguard of justice
Pregnant or breast-feeding women

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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.