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

NCT ID: NCT04884789

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2028-07-01

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.

Conditions

Burn Scar

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Post-Burn Face scar

Use of 3d printed TFO with silicone interface (COFIS 3D)

Group Type: EXPERIMENTAL

COFIS 3D

Intervention Type: DEVICE

Patient have to wear the COFIS 3D 20h a day for at least 6 month

Interventions

COFIS 3D

Patient have to wear the COFIS 3D 20h a day for at least 6 month

Intervention Type: DEVICE

Other Intervention Names

3d printed Transparent Face Orthosis with silicone interface

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clémence DEFFINIS, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Metz Thionville

Other Identifiers

2018-A03067-48

Identifier Type: -

Identifier Source: org_study_id