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临床试验/NCT01979757
NCT01979757已完成不适用

Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast After Breast-conserving Therapy

Bulovka Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Outcomes after centrifugation versus PureGraft for fatgrafting to the breast after breast-conserving therapy

研究概览

简要总结

Breast-conserving treatment (BCT) leads to a progressive and deteriorating breast deformity. Fatgrafting is ideal for breast reconstruction after BCT. The most frequently utilized technique for fat processing is centrifugation. The PureGraft device (Cytori Therapeutics, USA) is a new method that involves washing and filtering the fat to prepare the graft. The investigators compared the subjective and objective outcomes of two fat-processing methods, centrifugation and PureGraft filtration.

Thirty patients underwent breast reconstruction performed by a single surgeon (OM) after BCT in our department between April 2011 and September 2012. The patients were preoperatively divided into two groups randomly: 15 received fatgrafts processed by centrifugation, and 15 received fatgrafts processed by washing in PureGraft bags. The patients were followed up for 12-30 months.To measure the subjective outcome, the investigators distributed the BREAST-Q questionnaire to all the patients both preoperatively and one year postoperatively. The BCCT.core software evaluated the objective outcome of breast reconstruction by fatgrafting.

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 (Investigator)

入排标准

性别
Female
接受健康志愿者

入选标准

  • State after breast conserving therapy

排除标准

  • 未提供

结局指标

主要结局

Outcomes after centrifugation versus PureGraft for fatgrafting to the breast after breast-conserving therapy

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Bulovka Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ondrej Mestak M.D.

Consultant

Bulovka Hospital

研究点 (2)

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