Ignite Creation Date:
2024-07-17 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487910
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-19
Brief Title:
Differential Pressure Distribution Orthosis by 3D Printing Process in the Treatment of Post-burn Hypertrophic Scarring
Sponsor:
Centre Hospitalier Régional Metz-Thionville
Organization:
Centre Hospitalier Régional Metz-Thionville
Study Overview
Official Title:
Pilot Study on the Design of a 3D-printed Differential Pressure Distribution Orthosis for the Treatment of Post-burn Hypertrophic Scarring
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIDERM
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None