Pilot Study of a 3D-Printed Pressure Orthosis for Treating Post-Burn Hypertrophic Scars

What this Trial Is About

Researchers are evaluating a new 3D printing method to design a differential pressure distribution orthosis ORDP for treating post-burn hypertrophic scars. This pilot, single-center study aims to assess the feasibility of this innovative approach, as there has been no prior technical or clinical evaluation of ORDPs in this treatment context. The study also seeks to describe the production time and cost involved in this novel design process. Participants will undergo a 3D scan measurement of one or more burn scars, which will be digitally modified to prepare for manufacturing the ORDP. The orthosis will then be produced using a 3D printing process. This process and its outcomes will be closely observed during a short time frame shortly after inclusion. During the study, researchers will measure the success of orthosis manufacture, the time taken for conception and total design of the orthosis, and the overall fabrication cost. These assessments occur approximately 2 to 3 hours after participants are included. This single-group interventional study is sponsored by Centre Hospitalier Rgional Metz-Thionville and runs from January 2025 to January 2027.

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