A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site
研究概览
简要总结
The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.
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)
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
- •Documented history of previous breast surgery (either complete or partial mastectomy);
- •Available harvest sites for fat grafting as documented by plastic surgeon;
- •BMI > 20;
- •Anticipated harvested fat volume > 50cc;
- •Competency and willingness to provide consent
排除标准
- •Suspected or known to be pregnant
研究组 & 干预措施
REVOLVE Advanced Adipose System
Participants will receive the REVOLVE Advanced Adipose System technique during breast reconstruction.
干预措施: REVOLVE Advanced Adipose System (Device)
LipoGrafter
Participants will receive the LipoGrafter technique during breast reconstruction.
干预措施: LipoGrafter (Device)
Viality
Participants will receive the Viality technique during breast reconstruction.
干预措施: Viality (Procedure)
结局指标
主要结局
Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site
时间窗: Baseline, 90 day follow-up
3D volumetric scanning assesses the fat graft retention defined as the ratio of fat remaining at the surgical site at 90 day follow-up to that at pre-operative baseline.
Change in patient satisfaction of fat grafting technique, as measured by the BREAST-Q questionnaire
时间窗: Baseline, 90 day follow-up
The BREAST-Q questionnaire is used for measuring pre- and postoperative psychosocial, physical, and sexual well-being, satisfaction with breasts, experience of care, and satisfaction with outcome. Scores range on a 0-100 scale, with higher scores indicating better outcomes.
次要结局
- Number of palpable masses from the fat grafting technique, as measured by a physical exam.(90 day follow-up)
- Presence seroma from the fat grafting technique, as measured by a physical exam(90 day follow-up)
- Number of lesions of probable fat necrosis from the fat grafting technique, as measured by a physical exam(90 day follow-up)
- Presence of infection from the fat grafting technique, as measured by a physical exam(90 day follow-up)
- Assessment of wound healing from the fat grafting technique, as measured by a physical exam(90 day follow-up)