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

NCT06487910 | Recruiting

• 1 other identifier: 2024-01-CHRMT
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Burns; Hypertrophic Scar

Outcome Measures

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.

  2 to 3 hours after inclusion

Secondary Outcomes (3)

• Time of conception

  2 to 3 hours after inclusion

• Total time to design the orthosis

  2 to 3 hours after inclusion

• Total cost of the orthosis fabrication

  2 to 3 hours after inclusion

Study Arms (1)

3D scan measurment

EXPERIMENTAL

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

Interventions

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.

3D scan measurment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville/Hopital Félix Maréchal

Metz, 57000, France

RECRUITING

MeSH Terms

Conditions

Burns; Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Wounds and Injuries; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Loic BANASZAK

  CHR Metz Thionville Hopital Félix Maréchal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arpiné EL NAR, PhD

CONTACT

0033387557766; projet-recherche-clinique@chr-metz-thionville.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 5, 2024
• Study Start: January 10, 2025
• Primary Completion: January 10, 2026
• Study Completion: January 10, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)