A Randomized, Prospective Comparison of Methods to Process Autologous Fat Grafts in Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fat graft retention rate
研究概览
简要总结
This trial studies how well REVOLVE or PureGraft technique works in processing fat grafts for patients who are undergoing breast reconstruction. During breast reconstructive surgery that uses autologous fat grafting (transplanting fat tissue from one part of your body to another), fat tissue is removed from the body (usually the abdomen, buttock, or thighs) and injected into another part of the body. This tissue must be "processed" (sometimes referred to as "washed" or "prepared") before being inserted back into the body. It is not yet known whether REVOLVE or PureGraft technique may work better in retaining graft fat after surgery.
详细描述
PRIMARY OBJECTIVES:
I. To measure and compare the rate of fat graft retention, defined as the rate between the volume of fat remaining in the surgical site at one year and the volume of fat at baseline, associated with the use of two aforementioned adipose tissue processing techniques.
SECONDARY OBJECTIVES:
I. To measure early post-operative complications including infection, hematoma, delayed wound healing or seroma.
II. To measure late complications associated with fat grafting including fat necrosis, cyst formation, palpable mass, or breast asymmetry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Previous breast surgery, either mastectomy or partial mastectomy
- •Patients with available harvest sites for fat grafting
- •Patients with body mass index (BMI) > 20
- •Anticipated 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 and locally or distantly metastatic cancer
- •Patients who are unable to provide consent
- •Patients who are suspected or known to be pregnant
结局指标
主要结局
Fat graft retention rate
时间窗: At 1 year
Rate of fat graft retention, defined as the rate between the volume of fat remaining in the surgical site at one year and the volume of fat at baseline, associated with the use of the REVOLVE and PureGraft tissue processing techniques.
次要结局
未报告次要终点