ClinicalTrials.gg
RecruitingNCT06487910EPIDERMUpdated Jun 24, 2026

Differential Pressure Distribution Orthosis by 3D Printing Process in the Treatment of Post-burn Hypertrophic Scarring

An interventional study of 3D scan measurment in Burns and Hypertrophic Scar, sponsored by Centre Hospitalier Régional Metz-Thionville. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Centre Hospitalier Régional Metz-Thionville · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Burns
  • Hypertrophic Scar
03

In context

Burns

905 studies on the registry are indexed under Burns; 164 are open to participants now.

This study's planned enrollment of 25 is below the median of 40 across 663 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 123 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • Patient affiliated to a social security scheme

Exclusion criteria

Exclusion Criteria:

  • Patients under guardianship, curatorship or safeguard of justice
  • Pregnant or breast-feeding women
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    3D scan measurment

    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.

    Device: 3D scan measurment

Interventions

  • Device3D scan measurment

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 to 3 hours after inclusion

Secondary outcomes

  1. Time of conception

    Total time to make the orthosis (minutes)

    Time frame: 2 to 3 hours after inclusion

  2. Total time to design the orthosis

    Total time to design the orthosis (minutes)

    Time frame: 2 to 3 hours after inclusion

  3. Total cost of the orthosis fabrication

    Total cost of the orthosis fabrication (minutes)

    Time frame: 2 to 3 hours after inclusion

07

Study locations

1 of 1 sites recruiting
  • CHR Metz-Thionville/Hopital Félix Maréchal
    Metz, 57000, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06487910
Responsible party
Sponsor
First posted
Jul 5, 2024
Start date
Jan 10, 2025
Primary completion
Jan 10, 2027 (estimated)
Completion
Jan 10, 2027 (estimated)
Last update
Jun 24, 2026

Study contacts

Andreia CARVALHO DE FREITAS
Contact
projet-recherche-clinique@chr-metz-thionville.fr
0033387553323
Loic BANASZAK
principal investigator · CHR Metz Thionville Hopital Félix Maréchal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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