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临床试验/NCT05424666
NCT05424666招募中不适用

The Role of Lipofilling After Oncoplastic Breast Surgeries : Evaluation of Outcomes and Patient Satisfaction

Assiut University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Cosmetic apperance

研究概览

简要总结

The Role of Lipofilling After Oncoplastic Breast surgeries : Evaluation of Outcomes and Patient Satisfaction

详细描述

Lipofilling is the process of relocating autologous fat to change the shape, volume, consistency and profile of tissues. For over a century, surgeons have used autologous fat to enlarge and reshape the breasts.

Autologous fat grafting has gained popularity in recent years, although concerns exist regarding the safety and efficacy of this practice in breast surgery . Autologous fat grafting represents an important tool for the management of secondary contour deformities of reconstructed breasts; fat grafting is a simple, safe, and effective treatment option, with low morbidity. it is a straightforward and quick reconstructive technique that does not generally interfere with adjuvant therapies .patient surveys have demonstrated that irradiation has a significant and negative effect on patient satisfaction . Fat grafting seems to reduce radiation induced complications .improve cosmetic results, and reduce postoperative discomfort and pain. The aim of this study is to measure patient satisfaction with their breasts, as well as quality of life.

With the advent of liposuction in the 1980s, large amounts of unwanted fat could be removed from different body areas using small access incisions and a suction cannula. In this setting, fat grafting was re-introduced in the early 80s, pioneered by the American Mel Bircoll, who first described a series of fat transplantation for breast augmentation and reconstruction

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female gender.
  • Age of 18 years and older.
  • History or in candidate for a mastectomy in the near future.
  • Patients undergoing prophylactic mastectomy.
  • Patients' choice to undergo a breast reconstruction.
  • Wanting to participate in this study.
  • Patient is able to wear the BRAVA (BRA like VAcuum-based external tissue expander) device.

排除标准

  • Active smoker or a history of smoking 4 weeks prior to surgery.
  • Current substance abuse.
  • History of lidocaine allergy.
  • Four weeks or less after chemotherapy.
  • History of radiation therapy in the breast region.
  • Oncological treatment includes radiotherapy after mastectomy.
  • Kidney disease.
  • Steroid dependent (daily or weekly).
  • Immune-suppressed or immune-compromised disease.
  • Uncontrolled diabetes.
  • body mass index of >
  • Large breast size (ie, larger than cup C), unless the patient prefers reduction of the contralateral side towards cup C.
  • Extracapsular silicone leaking from the encapsulated implant from a previous breast reconstruction.

结局指标

主要结局

Cosmetic apperance

时间窗: 1 week

Volumetric evaluation of breast after surgery and symmetry to the other breast

次要结局

  • Complications during the treatment and follow up(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mina rashad helmy besada

Assiut lecturer

Assiut University

研究点 (2)

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