NCT06487910 Differential Pressure Distribution Orthosis by 3D Printing Process in the Treatment of Post-burn Hypertrophic Scarring
| NCT ID | NCT06487910 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Régional Metz-Thionville |
| Condition | Burns |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2027-01-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2025-01-10 with a primary completion date of 2027-01-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Loic BANASZAK
PRINCIPAL INVESTIGATOR
CHR Metz Thionville Hopital Félix Maréchal
Frequently Asked Questions
Who can join the NCT06487910 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Burns. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06487910 currently recruiting?
Yes, NCT06487910 is actively recruiting participants. Contact the research team at projet-recherche-clinique@chr-metz-thionville.fr for enrollment information.
Where is the NCT06487910 trial being conducted?
This trial is being conducted at Metz, France.
Who is sponsoring the NCT06487910 clinical trial?
NCT06487910 is sponsored by Centre Hospitalier Régional Metz-Thionville. The principal investigator is Loic BANASZAK at CHR Metz Thionville Hopital Félix Maréchal. The trial plans to enroll 25 participants.