Burn ScarECORCENCT04884789
Tolerance Assessment of Tailored 3d-printed TFO With Silicone Interface for the Treatment of Post-burn Face Scar
A study testing COFIS 3D in people with Burn Scar, run by Centre Hospitalier Régional Metz-Thionville.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Scar
- What is being tested?
- COFIS 3D
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official 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.
Read the 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
- Being tested
- COFIS 3D
- Keywords
- Burns, Transparent Face Orthosis, Silicone application, 3d Printed, Face
- Medical subject headings
- Burns, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COFIS 3DDevice
Also called 3d printed Transparent Face Orthosis with silicone interface
Patient have to wear the COFIS 3D 20h a day for at least 6 month
| Study group | Role | What they receive |
|---|---|---|
| Post-Burn Face scar | Experimental | Use of 3d printed TFO with silicone interface (COFIS 3D) Receives: Device: COFIS 3D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Local Side Effects
wound, device related pain, rash, temporomandibular joint pain, dental pain, suffocating sensation
Measured: Month 1
Secondary outcomes (8)
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.
Measured: 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).
Measured: Month 1; Month 6; Month 12; Month 18; Month 24
Wearing time
Diurnal and nocturnal wearing time in hours
Measured: Month 1; Month 6; Month 12; Month 18; Month 24
Manufacturing time
Time of device's manufacturing
Measured: Month 1; Month 6; Month 12; Month 18; Month 24
Reprints
Number of reprints needed per patient
Measured: 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
Measured: 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).
Measured: 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
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2028 (estimated)
Why it stopped: Principal investigator departure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clémence DEFFINIS, MD, Principal investigator, CHR Metz Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884789
- Sponsor's protocol ID
- 2018-A03067-48
- Acronym
- ECORCE
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2021
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance Assessment of Tailored 3d-printed Transparent Face Orthosis With Silicone Interface for the Treatment of Post-burn Face Scar
- ClinicalTrials.gov ID
- NCT04884789
- Acronym / sponsor ID
- ECORCE / 2018-A03067-48
- Conditions
- Burn Scar
- Keywords
- Burns, Transparent Face Orthosis, Silicone application, 3d Printed, Face
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal investigator departure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Burn Face scar | Experimental | Device: COFIS 3DUse of 3d printed TFO with silicone interface (COFIS 3D) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COFIS 3DAlso: 3d printed Transparent Face Orthosis with silicone interfacePatient have to wear the COFIS 3D 20h a day for at least 6 month | Device | Post-Burn Face scar |
Primary outcome
Number of Local Side Effects
Time frame: Month 1
wound, device related pain, rash, temporomandibular joint pain, dental pain, suffocating sensation
8 secondary outcomes
Evaluation of scar evolution with VSS
Time frame: Month 1; Month 6; Month 12; Month 18; Month 24
Evaluation of scar evolution with POSAS
Time frame: Month 1; Month 6; Month 12; Month 18; Month 24
Wearing time
Time frame: Month 1; Month 6; Month 12; Month 18; Month 24
Manufacturing time
Time frame: Month 1; Month 6; Month 12; Month 18; Month 24
Reprints
Time frame: Month 1; Month 6; Month 12; Month18; Month 24
Device lifetime
Time frame: Month 1; Month 6; Month 12; Month18; Month 24
Evaluation of the quality of life with the BSHS-B
Time frame: Month 1; Month 6; Month 12; Month 18; Month 24
Number of Local side effects
Time frame: Month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clémence DEFFINIS, MD principal investigator
CHR Metz Thionville
Questions about this trial
What is this clinical trial studying?
A study testing COFIS 3D in people with Burn Scar, run by Centre Hospitalier Régional Metz-Thionville.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Local Side Effects (time frame: Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.