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临床试验/NCT05190809
NCT05190809Unknown不适用

Immediate Breast Reconstruction With Hybrid Fat Transfer: Prospective Single-arm Interventional Study

Abouqir General Hospital2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
25
试验地点
2
主要终点
Immediate breast reconstruction and equalizing the operated breast cup size with the no-operated breast cup size

研究概览

简要总结

Investigators in this study describe a new perspective for female patients that will undergo skin-sparing mastectomy in which there will be an immediate reconstruction of the mastectomized breast for more satisfactory aesthetic results.

详细描述

This study introduces a new perspective for women who will undergo mastectomy especially Goldilocks mastectomy in which the investigators do fat grafting to the medial and lateral pillars of the breast as well as the inferior dermal flap in order to have a voluminous remaining breast shape that is close enough in size with the contralateral breast for more aesthetic results and to observe the lipografted tissue reaction after radiotherapy

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients
  • Age 20 - 65 years old
  • females with unilateral breast malignancy
  • candidate for Goldilocks mastectomy procedure

排除标准

  • Females with ages beyond the study frame.
  • Females refusing to participate
  • Fameles that not accepting the liposuction, lipofilling procedure
  • Females with contralateral previously operated or mastectomized breast.

结局指标

主要结局

Immediate breast reconstruction and equalizing the operated breast cup size with the no-operated breast cup size

时间窗: 6 months follow up post-surgical

fat grafting to the Goldilocks mastectomy flaps to have the mastectomized breast cup size to be aesthetically close to the contralateral non-operated breast cup size, also 5 point Likert scale was used to evaluate the patient satisfaction

次要结局

  • Evaluate the skin changes and the trophic effect of radiotherapy on the fat grafted tissue(through the radiotherapy course and 1 month after)

研究者

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

Ahmed Mohamed Abouzaid

Dr. Ahmed Mohamed Abouzaid

Abouqir General Hospital

研究点 (2)

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