Actively Recruiting
Pilot Study on the Design of a 3D-printed Differential Pressure Distribution Orthosis for the Treatment of Post-burn Hypertrophic Scarring
Led by Centre Hospitalier Régional Metz-Thionville · Updated on 2025-03-04
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new 3D printing method to design a special orthosis called a differential pressure distribution orthosis (ORDP) for treating post-burn hypertrophic scars. This pilot, single-center feasibility study aims to assess the technical and clinical process of creating these orthoses, as no prior evaluations have been done specifically for this treatment. The study will also describe the production time and cost involved with this innovative approach. Participants will have one or more burn scars measured using a 3D scan. This digital measurement will then be modified to prepare for manufacturing the ORDP using a 3D printing process. The study focuses on the success of creating the orthosis and will evaluate various aspects such as design time and fabrication cost. During the study, the primary outcome measured is the success of the orthosis manufacturing process within 2 to 3 hours after inclusion. Secondary outcomes include the time taken for conception, total design time, and total fabrication cost of the orthosis, all assessed within the same timeframe. Participants will be monitored closely during this short study period to understand the feasibility of this new design and production method.
CONDITIONS
Brief Title
Differential Pressure Distribution Orthosis by 3D Printing Process in the Treatment of Post-burn Hypertrophic Scarring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients under guardianship, curatorship or safeguard of justice
- Pregnant or breast-feeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - A few hours on the day of inclusion
Participants undergo a 3D scan measurement of one or more burn scars, which are then digitally modified to prepare for the manufacture of a differential pressure distribution orthosis using a 3D printing process.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
CHR Metz-Thionville/Hopital Félix Maréchal
Metz, France, 57000
Actively Recruiting
Research Team
A
Arpiné EL NAR, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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