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临床试验/NCT00663156
NCT00663156已完成不适用

A Prospective Study of Autologous Fat Grafting for Breast Augmentation

Georgetown University2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Effectiveness will be evaluated by comparing breast volume pre-operatively and at 1 year post-operatively using 3-dimensional picture imaging to obtain objective volume measurements.

研究概览

简要总结

This research study is to evaluate the natural history of fat transplanted from a person's body to their breasts. We are seeking a natural, safe, and effective alternative to breast implants. Patients will undergo liposuction of their body followed by infiltration of this harvested fat around their breasts. The study protocol will involve preoperative and postoperative photographs, mammograms, and MRI to look for changes in the breast shape and size, as well as any internal changes in the breast tissue.

详细描述

The current standard for breast augmentation involves placement of an implant. Although implants are safe, they are foreign bodies and thus have inherent risks including infection, failure, malposition, etc. In order to avoid the inherent risks of an implanted device, some surgeons and patients have elected to proceed with breast augmentation from autologous tissue. Early reports of autologous fat transplantation to the breasts were successful, but increases in breast volume were modest (Bircoll, 1987). There were also hypothetical concerns about changes in the breast tissue that would interfere with mammographic screening for breast cancer.

Spear et al (2005) performed autologous fat transplantation to reconstructed breasts in 37 patients with 2-dimensional photographic evidence of improved breast shape and volume suggesting that this technique can be effectively performed. However, these patients had all received mastectomies so mammographic screening was not indicated. Coleman and Saboeiro (2007) performed autologous fat transplantation to the breasts in 17 patients. Fifteen of the 17 patients received post-operative mammograms, 7 (47%) of which were abnormal. However, none of these abnormal findings interfered with cancer screening. Furthermore, 2 patients in the study did develop breast cancer which was successfully detected by mammography. Other studies have confirmed the ability to differentiate benign from malignant findings on mammogram after autologous fat transplantation. Pulagam et al (2006) reported long term (10 and 8 year) findings on 2 patients that underwent autologous fat transplantation to the breasts. Mammography and ultrasound were used to differentiate benign from malignant appearing calcifications. Some authors have speculated that autologous fat transplantation to the breast would lead to mammographic changes similar to routine breast procedures such as breast reduction and mastopexy (Coleman and Saboeiro, 2007).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • 20-50 years old
  • willing to have mammogram, MRI, and photographs
  • willing to follow study requirements and sign informed consent
  • no previous breast surgeries
  • must reside within 50 miles of the Washington, D.C. Metropolitan area

排除标准

  • pregnant or nursing
  • existing breast cancer
  • advanced fibrocystic disease
  • protease inhibitors
  • any condition leading to surgical risk
  • any disease known to affect wound healing
  • abscess or infection in the body
  • incompatible psychological factors

结局指标

主要结局

Effectiveness will be evaluated by comparing breast volume pre-operatively and at 1 year post-operatively using 3-dimensional picture imaging to obtain objective volume measurements.

时间窗: One year post-op

次要结局

  • Patients will be evaluated by mammogram, MRI, and 3-D photography to monitor for breast tissue abnormalities and measure increase in volume(one year)

研究者

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

Scott L. Spear, M.D.

Chief Plastic Surgery

Georgetown University

研究点 (2)

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