Differential Pressure Distribution Orthosis by 3D Printing Process in the Treatment of Post-burn Hypertrophic Scarring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D scan measurment.
- Who it may be relevant to
- Registry conditions: Burns, Hypertrophic Scar. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study on the Design of a 3D-printed Differential Pressure Distribution Orthosis for the Treatment of Post-burn Hypertrophic Scarring
Overview
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
- Device 3D 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.
Primary outcome measures
- Sucess of the manufacture process of the orthosis [Time frame: 2 to 3 hours after inclusion]
Secondary outcome measures (3)
- Time of conception [Time frame: 2 to 3 hours after inclusion]
- Total time to design the orthosis [Time frame: 2 to 3 hours after inclusion]
- Total cost of the orthosis fabrication [Time frame: 2 to 3 hours after inclusion]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHR Metz-Thionville/Hopital Félix Maréchal — Metz
Identifiers
NCT: NCT06487910 · 2024-01-CHRMT