Burn Scar Clinical Trial
— ECORCEOfficial title:
Tolerance Assessment of Tailored 3d-printed Transparent Face Orthosis With Silicone Interface for the Treatment of Post-burn Face Scar
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.
Status | Not yet recruiting |
Enrollment | 13 |
Est. completion date | April 1, 2028 |
Est. primary completion date | April 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional Metz-Thionville |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Local Side Effects | wound, device related pain, rash, temporomandibular joint pain, dental pain, suffocating sensation | Month 1 | |
Secondary | Evaluation of scar evolution with VSS | Vancouver Scar Scale (VSS) assesses 4 variables: vascularity (range 0-3), height/thickness (range 0-3), pliability (range 0-5) and pigmentation (0-2). A total scores ranges from 0 to 13, whereby a score of 0 reflects normal skin. | Month 1; Month 6; Month 12; Month 18; Month 24 | |
Secondary | Evaluation of scar evolution with POSAS | Evaluation of scar evolution by Patient and Observer Scar Assessment Scale (POSAS). It consists of two scales which assesses vascularity, pigmentation, thickness, relief, pliability, and surface area and it incorporates patient assessment of pain, itching, color, stiffness, thickness and relief. All items were evaluated on numerical rating scales ranging from 1 to 10 (with 10 indicating the worst score). | Month 1; Month 6; Month 12; Month 18; Month 24 | |
Secondary | Wearing time | Diurnal and nocturnal wearing time in hours | Month 1; Month 6; Month 12; Month 18; Month 24 | |
Secondary | Manufacturing time | Time of device's manufacturing | Month 1; Month 6; Month 12; Month 18; Month 24 | |
Secondary | Reprints | Number of reprints needed per patient | Month 1; Month 6; Month 12; Month18; Month 24 | |
Secondary | Device lifetime | Device lifetime corresponds to the time between implementation and change of device (for any Reason) in days | Month 1; Month 6; Month 12; Month18; Month 24 | |
Secondary | Evaluation of the quality of life with the BSHS-B | Evaluation of the quality of life of patients by the BSHS-B (Burn Specific Health Scale - Brief). The BSHS-B consists of 40 items divided into four domains with nine subscales (heat sensitivity, affect, hand function, treatment regimens, work, sexuality, interpersonal relationships, simple abilities and body change). Items are answered on a 5-point Likert scale ranging from 0 (extremely) to 4 (not at all). | Month 1; Month 6; Month 12; Month 18; Month 24 | |
Secondary | Number of Local side effects | wound, device related pain, rash, temporomandibular joint pain, dental pain, suffocating sensation | Month 6 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03664505 -
Evaluation of the Product Properties of Individualized 3D-compression Garments to Treat Scars
|
N/A | |
Recruiting |
NCT05309720 -
Dermal Substitution in Pediatric Burns
|
N/A | |
Not yet recruiting |
NCT04995302 -
Microneedling Therapy With or Without Amnion Bilayer Sheeting on Scar Tissue
|
N/A | |
Not yet recruiting |
NCT04557514 -
Comparative Study Between Fat Injection And Platelet Rich Plasma In Post Burn Facial Scar
|
N/A | |
Recruiting |
NCT05555602 -
Observation of the Comfort and Efficacy of CO2 Laser Combined With Cryo 6 for Burn or Linear Scars.
|
N/A | |
Recruiting |
NCT05610878 -
Efficacy of Preconditioned Adipose-Derived Stem Cells in Fat Grafting
|
Phase 1 | |
Recruiting |
NCT01619917 -
The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars
|
N/A | |
Recruiting |
NCT01488240 -
The Role of Pulsed Dye Laser Therapy in the Management of Burn Scars
|
N/A | |
Completed |
NCT03197649 -
CO2 Laser Phototherapy for Management of Mature Burn Scars
|
N/A | |
Completed |
NCT04619589 -
Characterization of Dyschromic Hypertrophic Scar
|
||
Completed |
NCT03627650 -
Fat Grafting in Skin-grafted Deep Burn Scars
|
N/A | |
Completed |
NCT02417818 -
Cutaneous Microcirculation After Plasma Therapy
|
N/A | |
Completed |
NCT02417779 -
Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy
|
N/A | |
Withdrawn |
NCT01075165 -
Efficacy of Spray Silicone in Alteration of Burn Scar
|
N/A | |
Recruiting |
NCT04364217 -
Pain and Itch Reduction in Burn Scars Treated With Fractional CO2 Laser
|
N/A | |
Completed |
NCT04412759 -
PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS
|
N/A | |
Recruiting |
NCT06122090 -
Treatment of Hypopigmented Scars With Bimatoprost
|
Phase 2 | |
Recruiting |
NCT05423613 -
Microneedling for Burn Hypertrophic Scars
|
N/A | |
Active, not recruiting |
NCT04456127 -
CO2 Laser Revision for Burn Related Donor Site Scars
|
N/A | |
Completed |
NCT03544697 -
Easy Way of Choosing Rectangular Expander and Getting Maximum Benefit From Expanded Tissue
|