BurnsEPIDERMNCT06487910
Differential Pressure Distribution Orthosis by 3D Printing Process in the Treatment of Post-burn Hypertrophic Scarring
A study testing 3D scan measurment in people with Burns and Hypertrophic Scar, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
This is a pilot, single-center, feasibility study to evaluate a new 3D printing method for ORDP design. To our knowledge, there is no technical or clinical evaluation of ORDPs, particularly in the treatment of hypertrophic scars. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Hypertrophic Scar
- What is being tested?
- 3D scan measurment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2025to 10 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult Patients aged > 18 years old
- Patient with at least one hypertrophic burn scar in the process of healing localized on a skin area that can benefit from a compression garment and requiring the use of an ORDP
- Patient able to give informed consent
- Patient affiliated to a social security scheme
Who cannot join
- Patients under guardianship, curatorship or safeguard of justice
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHR Metz-Thionville/Hopital Félix Maréchal
Metz, 57000
Andreia CARVALHO DE FREITAS, 0033387553323, projet-recherche-clinique@chr-metz-thionville.fr
Loic BANASZAK
About this study
Official title: Pilot Study on the Design of a 3D-printed Differential Pressure Distribution Orthosis for the Treatment of Post-burn Hypertrophic Scarring
This is a pilot, single-center, feasibility study to evaluate a new 3D printing method for ORDP design.
To our knowledge, there is no technical or clinical evaluation of ORDPs, particularly in the treatment of hypertrophic scars. The aim of our study is therefore to assess the feasibility of an innovative method of designing ORDPs for the curative treatment of post-burn hypertrophic scars, using a 3D printing process, and to describe the procedures (production time and cost).
- Conditions
- Burns, Hypertrophic Scar
- Being tested
- 3D scan measurment
- Medical subject headings
- Burns, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D scan measurmentDevice
patients included in the study will undergo a 3D scan measurement of on or more burn scars. This measurement will then be digitally modified in preparation for the manufacture of the "differential pressure distribution orthosis". The orthosis will then be manufactured using a 3D printing process.
| Study group | Role | What they receive |
|---|---|---|
| 3D scan measurment | Experimental | patients included in the study will undergo a 3D scan measurement of on or more burn scars. This measurement will then be digitally modified in preparation for the manufacture of the "differential pressure distribution orthosis". The orthosis will then be manufactured using a 3D printing process. Receives: Device: 3D scan measurment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sucess of the manufacture process of the orthosis
Defined as the compliance with all three of the following specifications: 1) oval shapes are approximately 2 mm thick, 2) absence of wounding areas (prickly or sharp), 3) a satisfactory morphological match with the area to be treated.
Measured: 2 to 3 hours after inclusion
Secondary outcomes (3)
Time of conception
Total time to make the orthosis (minutes)
Measured: 2 to 3 hours after inclusion
Total time to design the orthosis
Total time to design the orthosis (minutes)
Measured: 2 to 3 hours after inclusion
Total cost of the orthosis fabrication
Total cost of the orthosis fabrication (minutes)
Measured: 2 to 3 hours after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start10 Jan 2025
- Primary completion10 Jan 2027 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loic BANASZAK, Principal investigator, CHR Metz Thionville Hopital Félix Maréchal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487910
- Sponsor's protocol ID
- 2024-01-CHRMT
- Acronym
- EPIDERM
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Design of a 3D-printed Differential Pressure Distribution Orthosis for the Treatment of Post-burn Hypertrophic Scarring
- ClinicalTrials.gov ID
- NCT06487910
- Acronym / sponsor ID
- EPIDERM / 2024-01-CHRMT
- Conditions
- Burns, Hypertrophic Scar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 5 Jul 2024 (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.
This is a pilot, single-center, feasibility study to evaluate a new 3D printing method for ORDP design.
To our knowledge, there is no technical or clinical evaluation of ORDPs, particularly in the treatment of hypertrophic scars. The aim of our study is therefore to assess the feasibility of an innovative method of designing ORDPs for the curative treatment of post-burn hypertrophic scars, using a 3D printing process, and to describe the procedures (production time and cost).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D scan measurment | Experimental | Device: 3D scan measurmentpatients included in the study will undergo a 3D scan measurement of on or more burn scars. This measurement will then be digitally modified in preparation for the manufacture of the "differential pressure distribution orthosis". The orthosis will then be manufactured using a 3D printing process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult Patients aged > 18 years old
- Patient with at least one hypertrophic burn scar in the process of healing localized on a skin area that can benefit from a compression garment and requiring the use of an ORDP
- Patient able to give informed consent
- Patient affiliated to a social security scheme
Key exclusion criteria (2 listed)
- Patients under guardianship, curatorship or safeguard of justice
- Pregnant or breast-feeding 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 |
|---|---|---|
| 3D scan measurmentpatients included in the study will undergo a 3D scan measurement of on or more burn scars. This measurement will then be digitally modified in preparation for the manufacture of the "differential pressure distribution orthosis". The orthosis will then be manufactured using a 3D printing process. | Device | 3D scan measurment |
Primary outcome
Sucess of the manufacture process of the orthosis
Time frame: 2 to 3 hours after inclusion
Defined as the compliance with all three of the following specifications: 1) oval shapes are approximately 2 mm thick, 2) absence of wounding areas (prickly or sharp), 3) a satisfactory morphological match with the area to be treated.
3 secondary outcomes
Time of conception
Time frame: 2 to 3 hours after inclusion
Total time to design the orthosis
Time frame: 2 to 3 hours after inclusion
Total cost of the orthosis fabrication
Time frame: 2 to 3 hours after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Loic BANASZAK principal investigator
CHR Metz Thionville Hopital Félix Maréchal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D scan measurment in people with Burns and Hypertrophic Scar, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreia CARVALHO DE FREITAS (0033387553323, projet-recherche-clinique@chr-metz-thionville.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sucess of the manufacture process of the orthosis (time frame: 2 to 3 hours after inclusion). 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 24 Jun 2026.