Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery - a Pilot Study
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
- 2
- 主要终点
- Adipose tissue dependent take rate
研究概览
简要总结
The primary aim of this project is to standardize the method for lipofilling by identifying the best technique. In this context, the study will investigate the impact of adipose tissue composition and ideal quantity of the injected fat particularly in view of resorption rate. Correlations between adipose tissue composition, amount of transferred fat, already existing subcutaneous fat layer at the grafting site and resorption rate will be made.
The punch biopsy and the non-invasive Lipometer measurements to determine the subcutaneous fat layer thickness in the harvesting and grafting region will be performed in 10 female subjects that undergo elective lipofilling.
The study was registered on Clinicaltrials.gov after start of recruitment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women, age 18-70 years (limited upwards due to the indication for lipofilling and the amount of possible secondary diseases)
- •History of BRCA1 and BRCA2 - positive breast cancer with following subcutaneous mastectomy
- •Planned, elective breast-lipofilling
- •Thickness of the skin and subcutaneous fat layer of min. 1 cm (detected via sonography)
- •Currently healthy individual, willing to participate in this study
排除标准
- •Previous surgery at the harvesting site (e.g. caesarian section)
- •Pregnancy or planned pregnancy
- •Current or preceded chemotherapy
- •Preceded radiatio
- •Unable to fully understand study procedures and to provide informed consent
结局指标
主要结局
Adipose tissue dependent take rate
时间窗: 12-24 months
Detect an adipose tissue composition-dependent take rate
次要结局
未报告次要终点