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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreia CARVALHO DE FREITAS | Contact | 0033387553323 | projet-recherche-clinique@chr-metz-thionville.fr |
| Name | Affiliation | Role |
|---|---|---|
| Loic BANASZAK | CHR Metz Thionville Hopital Félix Maréchal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR Metz-Thionville/Hopital Félix Maréchal | Recruiting | Metz | 57000 | France |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |