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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional Metz-Thionville

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients under guardianship, curatorship or safeguard of justice

Pregnant or breast-feeding women

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: 3D scan measurmentExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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