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

Not Applicable

Recruiting

• Conditions: Burns; Hypertrophic Scar
• Interventions: Device: 3D scan measurment

• Registration Number: NCT06487910
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-27
• Study First Posted: 2024-07-05
• Study Start: 2025-01-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Primary Completion: 2026-01-10
• Study Completion: 2026-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D scan measurment	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.

Primary Outcome Measures

Name	Time	Method
Sucess of the manufacture process of the orthosis	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 Outcome Measures

Name	Time	Method
Total time to design the orthosis	2 to 3 hours after inclusion	Total time to design the orthosis (minutes)
Time of conception	2 to 3 hours after inclusion	Total time to make the orthosis (minutes)
Total cost of the orthosis fabrication	2 to 3 hours after inclusion	Total cost of the orthosis fabrication (minutes)

Trial Locations

Locations (1)

CHR Metz-Thionville/Hopital Félix Maréchal; 🇫🇷 Metz, France