Evaluation of the Product Properties of Individualized 3D-compression Garments to Treat Scars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Fitting of the garment (on a numeric rating scale 0-10)
研究概览
简要总结
Burn scars are treated with compression garments. These are produced based on manual measure data. The aim of this study is to evaluate correct fitting, wearing comfort, suitability for daily use and scar properties after using garments produced on base of measuring data from scanning in comparison to manual measured data.
详细描述
In plastic and reconstructive surgery, treatment of burn scars is still challenging, because excessive and hypertrophic scarring can occur. Burn garments are usually used to reduce such scarring. However, measure are taken manually by a measuring tape using interpolation. Therefore, compression garments produced on base of 3D surface imaging using a scanning system are compared to compression garments based on manually measurements regarding correct fitting, wearing comfort, suitability for daily use and scar properties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The patient receives two different burn garments and does not know which one was produced based on the scan data and which one on the manual measuring.
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
- •Burn scars on an arm after IIa-III. burn (1-30% surface area)
- •Indication for burn garments
- •Experience in using burn garments
排除标准
- •Consume of pain killer
- •Medication with cortisone or immun suppressive therapy
- •Psychiatric disease
研究组 & 干预措施
Garment based on manual measurement
Garment based on manual measurement is used on burn scar
干预措施: Compression garment (manual) (Device)
Garment based on scan measurement
Garment based on scan measurement is used on burn scar
干预措施: Compression garment (scan) (Device)
结局指标
主要结局
Fitting of the garment (on a numeric rating scale 0-10)
时间窗: 3 months
Numeric rating scale from 0 (minimum) to 10 (maximum) judged by the patient: 0 means perfect fitting, 10 means no fitting). Higher values represent a worse outcome.
次要结局
- Comfort of the garment (on a numeric rating scale 0-10)(3 months)
- Daily use of the garment (on a numeric rating scale 0-10)(3 months)
研究者
Tobias Kisch
Principal Investigator
University Hospital Schleswig-Holstein