Pilot Study on the Design of a 3D-printed Differential Pressure Distribution Orthosis for the Treatment of Post-burn Hypertrophic Scarring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Sucess of the manufacture process of the orthosis
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients under guardianship, curatorship or safeguard of justice
- •Pregnant or breast-feeding women
研究组 & 干预措施
3D scan measurment
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.
干预措施: 3D scan measurment (Device)
结局指标
主要结局
Sucess of the manufacture process of the orthosis
时间窗: 2 to 3 hours after inclusion
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.
次要结局
- Total time to design the orthosis(2 to 3 hours after inclusion)
- Time of conception(2 to 3 hours after inclusion)
- Total cost of the orthosis fabrication(2 to 3 hours after inclusion)