Clinical trial NCT04884789: Tolerance Assessment of Tailored 3d-printed TFO With Silicone Interface for the Treatment of Post-burn Face Scar
Official title: Tolerance Assessment of Tailored 3d-printed Transparent Face Orthosis With Silicone Interface for the Treatment of Post-burn Face Scar
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Burn Scar
Keywords: Burns
Transparent Face Orthosis
Silicone application
3d Printed
Face
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Local Side Effects
timeFrame: Month 1
Secondary outcomes:
measure: Evaluation of scar evolution with VSS
timeFrame: Month 1; Month 6; Month 12; Month 18; Month 24
measure: Evaluation of scar evolution with POSAS
timeFrame: Month 1; Month 6; Month 12; Month 18; Month 24
measure: Wearing time
timeFrame: Month 1; Month 6; Month 12; Month 18; Month 24
measure: Manufacturing time
timeFrame: Month 1; Month 6; Month 12; Month 18; Month 24
measure: Reprints
timeFrame: Month 1; Month 6; Month 12; Month18; Month 24
measure: Device lifetime
timeFrame: Month 1; Month 6; Month 12; Month18; Month 24
measure: Evaluation of the quality of life with the BSHS-B
timeFrame: Month 1; Month 6; Month 12; Month 18; Month 24
measure: Number of Local side effects
timeFrame: Month 6
Other outcomes:
Locations:
Study officials:
affiliation: CHR Metz Thionville
name: Clémence DEFFINIS, MD
role: PRINCIPAL_INVESTIGATOR
References: