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NCT Number: NCT06487910

Differential Pressure Distribution Orthosis by 3D Printing Process in 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).

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Key information

Conditions

Burns Cicatrix Cicatrix, Hypertrophic Fibrosis Hypertrophic Scar Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR Metz-Thionville/Hopital Félix Maréchal

Metz, 57000, France

Location status: Recruiting

Location contact

Andreia CARVALHO DE FREITAS

CONTACT

[email protected]

0033387553323

Loic BANASZAK

PRINCIPAL_INVESTIGATOR

Marie CUNY-TORRES

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent
  • Patient affiliated to a social security scheme

Exclusion criteria

  • Patients under guardianship, curatorship or safeguard of justice
  • Pregnant or breast-feeding women

Treatment and study plan

3D scan measurment

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time of conception

    Time frame: 2 to 3 hours after inclusion

    Total time to make the orthosis (minutes)

  2. Total time to design the orthosis

    Time frame: 2 to 3 hours after inclusion

    Total time to design the orthosis (minutes)

  3. Total cost of the orthosis fabrication

    Time frame: 2 to 3 hours after inclusion

    Total cost of the orthosis fabrication (minutes)

Study contacts

Contact information is provided by the study sponsor or research team.

Andreia CARVALHO DE FREITAS

CONTACT

[email protected]

0033387553323

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

Pilot Study on the Design of a 3D-printed Differential Pressure Distribution Orthosis for the Treatment of Post-burn Hypertrophic Scarring

Acronym: EPIDERM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 5, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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