Status:
WITHDRAWN
Tolerance Assessment of Tailored 3d-printed TFO With Silicone Interface for the Treatment of Post-burn Face Scar
Lead Sponsor:
Centre Hospitalier Régional Metz-Thionville
Conditions:
Burn Scar
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the tolerance of tailored 3d-printed transparent face orthosis used in the medical care of post-burn face scar.
Detailed Description
Burn injuries are not a rare affection. According to WHO (World Health Organization), in 2004 there were 11 million peoples in the world who were affected by burn injuries caused by fire and who neede...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Post-Burn Face scar during maturation stage or surgical intervention on post-burn face scar during maturation stage
- Patient agrees to shave beard if necessary for 3D camera measurement
- Patient able to express informed consent
- Affiliation to a social security scheme
Exclusion
- Post burn face scar in the sequela stage
- Patient with unbalanced photosensitive epilepsy
- Patient with an unconsolidated fracture of the face's bones or skull
- Patient with a known allergy to silicone
- Pregnant or lactating women
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04884789
Start Date
January 1 2025
End Date
July 1 2028
Last Update
March 7 2025
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