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

Centre Hospitalier Régional Metz-Thionville

Status: Enrolling

Conditions: Hypertrophic Scar; Burns

Treatments: Device: 3D scan measurment

Study type: Interventional

Funder types: Other

Identifiers

NCT06487910

2024-01-CHRMT

Details and patient eligibility

About

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).

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

3D scan measurment

Experimental group

Description:

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.

Treatment:

Device: 3D scan measurment