3D printed orthosis for treating post-burn scars
Pilot Study on the Design of a 3D-printed Differential Pressure Distribution Orthosis for the Treatment of Post-burn Hypertrophic Scarring
This study is testing a new way to make custom 3D-printed devices to help heal thick scars from burns and see if they are easy to make and affordable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Régional Metz-Thionville Academic / other |
| Locations | 1 site (Metz) |
| Trial ID | NCT06487910 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility of using a 3D printing method to design orthotic devices specifically for the treatment of hypertrophic scars resulting from burns. The study focuses on assessing the production time and cost associated with creating these devices, which are intended to provide differential pressure distribution to aid in scar healing. By utilizing advanced 3D scanning and printing technologies, the research aims to innovate the approach to scar management in patients recovering from burns.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with at least one hypertrophic burn scar that requires treatment with a compression garment.
Not a fit: Patients who are pregnant, breastfeeding, or under legal guardianship will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the healing process and cosmetic outcomes for patients with hypertrophic scars.
How similar studies have performed: While this approach is innovative and has not been extensively evaluated in prior studies, the use of 3D printing in medical applications has shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Metz
- CHR Metz-Thionville/Hopital Félix Maréchal — Metz, France (Recruiting)
Study contacts
- Principal investigator: Loic BANASZAK — CHR Metz Thionville Hopital Félix Maréchal
- Study coordinator: Arpiné EL NAR, PhD
- Email: projet-recherche-clinique@chr-metz-thionville.fr
- Phone: 0033387557766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.