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

Pilot Study on the Design of a 3D-printed Differential Pressure Distribution Orthosis for 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).

Study Overview

• Status: Recruiting
• Conditions: Burns; Hypertrophic Scar
• Intervention / Treatment: Device: 3D scan measurment

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arpiné EL NAR, PhD; Phone Number: 0033387557766; Email: projet-recherche-clinique@chr-metz-thionville.fr

Study Locations

• France
  • Metz, France, 57000
    • Recruiting
    • CHR Metz-Thionville/Hopital Félix Maréchal
    • Contact: Arpiné EL NAR, PhD; Phone Number: 0033387557766; Email: projet-recherche-clinique@chr-metz-thionville.fr
    • Principal Investigator: Loic BANASZAK
    • Sub-Investigator: Marie CUNY-TORRES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 to 3 hours after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of conception	Total time to make the orthosis (minutes)	2 to 3 hours after inclusion
Total time to design the orthosis	Total time to design the orthosis (minutes)	2 to 3 hours after inclusion
Total cost of the orthosis fabrication	Total cost of the orthosis fabrication (minutes)	2 to 3 hours after inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Loic BANASZAK, CHR Metz Thionville Hopital Félix Maréchal

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): January 10, 2026
• Study Completion (Estimated): January 10, 2026

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Pathological Conditions, Anatomical; Cicatrix; Fibrosis; Hypertrophy; Burns; Cicatrix, Hypertrophic
• Other Study ID Numbers: 2024-01-CHRMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No