A Randomized, Prospective Comparison of Time Associated With Techniques to Process Autologous Fat Grafts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of fat processed defined as the volume of fat harvested per minute
研究概览
简要总结
This randomized clinical trial studies and compares 3 techniques in performing autologous fat grafting (AFG) in patients undergoing surgery to reshape or rebuild (reconstruct) a part of the body changed by previous surgery and inserted into another part of the body. AFG, also called fat injections or fat transplant, is a procedure in which an individual's own body fat (usually from abdomen or legs) is used during reconstructive surgery. Doctors want to compare 3 techniques for processing the fat tissue collected during surgery and the length of time needed to complete each AFG technique and surgery. Comparing 3 AFG techniques and the time to complete them during surgery may help doctors determine the best technique to perform fat grafting in the future.
详细描述
PRIMARY OBJECTIVES:
I. Measure and compare the rate of fat processed, defined as the volume of fat processed per unit time associated with the use of three aforementioned adipose tissue processing techniques.
SECONDARY OBJECTIVES:
I. To measure total fat grafting time: time from initiation of fat harvesting to the end of fat injection.
II. To measure volume of fat processed: volume of fat obtained after fat processing.
研究设计
- 研究类型
- Observational
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
- •Patients with available harvest sites for fat grafting
- •Patients with body mass index (BMI) > 20
- •Estimated harvested fat volume >= 100 cc
- •Patients are willing and able to give consent
排除标准
- •Patients with active cancer, including primary cancer, recurrent cancer, or locally or distant metastasis
- •Patients who are unable to provide consent
- •Patients who are suspected or known to be pregnant
结局指标
主要结局
Rate of fat processed defined as the volume of fat harvested per minute
时间窗: 1 day
Study data will be collected and managed using the Research Electronic Data Capture. This study will measure and compare the rate of fat processed, defined as the volume of fat processed per unit time associated with the use of three adipose tissue processing techniques.
次要结局
未报告次要终点