Brava and Fat Transfer for Breast Reconstruction
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 主要终点
- Number of patients satisfied with breast reconstruction using Brava and fat transfer
研究概览
简要总结
Breast reconstruction is one of the most challenging aspects in plastic surgery. One of the most sophisticated methods of breast reconstruction is using of autologous fat grafting. Brava is a device that invented by Dr Roger Khouri, and is intended to improve the final results of fat grafting.
详细描述
The purpose of the study is to examine the efficacy of Brava with fat grafting in woman undergoing mastectomy in the institution. Woman who will agree to participate in the study will be instructed how to wear the Brava, and after 200 hours of using the device they will be operated for fat transfer to the breast in order to reconstruct it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •woman after mastectomy
排除标准
- •collagen disease
- •low compliance
结局指标
主要结局
Number of patients satisfied with breast reconstruction using Brava and fat transfer
时间窗: 6 months
patients undergoing breast mastectomy will undergo breast reconstruction using the Brava and fat transfer, and will be assessed by a certified plastic surgeon who will not be a part of the study.
次要结局
未报告次要终点
研究者
Yoav Gronovich
Certified Plastic Surgeon
Shaare Zedek Medical Center