Tolerance Assessment of Tailored 3d-printed TFO With Silicone Interface for the Treatment of Post-burn Face Scar

Study Overview
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Brief Summary
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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
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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 needed medical cares. This important number ignores non-fire thermal, chemical and electrical burns. Face is one of the most susceptible areas of burn where the prevalence was reported to be 6-60%. Hypertrophic scars (HS) are frequent consequences of dermal burn with a prevalence of 70% of burned people. HS, which are a dermal fibro-proliferation, are rigid, erythematous and thickened scars associated with pigmentation abnormalities, xerosis, thermal sensitivity, pain and pruritus. When HS is located on the face, they can cause cosmetic disorder with disfigurement and psychological distress. Pressure therapy and silicone application are the two recommended non-invasive care for prevention and treatment of hypertrophic scarring after burn. On the face, Pressure Garment Therapy (PGT) cannot exert the required pressure because of concave or flat shape so the use of face mask is the most common form of pressure therapy on the face. The face mask manufacturing is artisanal, time consuming and variable between all burn centers. They are not very accurate and have difficulties to apply effective pressure on certain face areas such as nasolabial folds. Our Transparent Face Orthosis (TFO) uses tri-dimensional cam for measurement and 3d-printing technology for manufacturing. We think this way to manufacture the TFO will be more accurate and efficient, less expansive and time consuming. Moreover, the addition of a silicone interface between the TFO and the face will associate silicone application therapy and pressure therapy what should be more effective than pressure therapy alone. 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.

Official Title
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Tolerance Assessment of Tailored 3d-printed Transparent Face Orthosis With Silicone Interface for the Treatment of Post-burn Face Scar

Conditions
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Burn Scar

Intervention / Treatment
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* Device: COFIS 3D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post-Burn Face scar<br>Use of 3d printed TFO with silicone interface (COFIS 3D) | Device: COFIS 3D<br>* Patient have to wear the COFIS 3D 20h a day for at least 6 month<br>* Other names: 3d printed Transparent Face Orthosis with silicone interface;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Local Side Effects | wound, device related pain, rash, temporomandibular joint pain, dental pain, suffocating sensation | Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Wearing time | Diurnal and nocturnal wearing time in hours | Month 1; Month 6; Month 12; Month 18; Month 24 | 
| Manufacturing time | Time of device's manufacturing | Month 1; Month 6; Month 12; Month 18; Month 24 | 
| Reprints | Number of reprints needed per patient | Month 1; Month 6; Month 12; Month18; Month 24 | 
| 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 | 
| 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 | 
| Number of Local side effects | wound, device related pain, rash, temporomandibular joint pain, dental pain, suffocating sensation | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns, Transparent Face Orthosis, Silicone application, 3d Printed, Face