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临床试验/NCT02201979
NCT02201979已完成不适用

Laser Fluorescent Imaging of Nipple and Areola During Breast Lift in Combination With Breast Implants

Swanson Center1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年7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
15
试验地点
1
主要终点
Blood supply to breast as evaluated by laser fluorescent imaging

研究概览

简要总结

Breast lift surgery performed in combination with breast implants is a common cosmetic operation. However, there have been concerns regarding the safety of this treatment combination. Some investigators are concerned that an implant may increase the risk of complications, including loss of circulation to the nipple and areola. This study was undertaken to evaluate the blood supply of the breast using intraoperative laser fluorescent imaging and to determine whether a breast implant compromises blood supply to the nipple and areola.

详细描述

Protocol

Laser Fluorescent Imaging of Breasts During Vertical Breast Lifts and Reductions Performed in Combination with Breast Implants.

Background/Purpose

Today, breast lifts are a common operation. Implants may be recommended to provide greater fullness of the upper poles of the breasts. One of the risks of surgery is compromised circulation to the nipples and areolae. Some investigators believe that the simultaneous insertion of breast implants adds to the risk by causing pressure on the overlying breast tissue and skin.1 Staging the procedure (first the breast lift and then implants or vice versa) has been recommended, but staging is inconvenient and costly for patients, necessitating two operations. Clinical experience with the newer vertical breast lift technique, as opposed to the traditional inferior pedicle technique, has been favorable, with few reported complications.2 The vertical technique uses a shorter, more superficial pedicle than the traditional inferior pedicle, with a more reliable blood supply.2 A breast lift and reduction are essentially the same operation; more breast tissue is removed during a reduction but the dissection is the same.

This study was undertaken to investigate the blood supply to the nipples and areolae during the combined breast lift/reduction and implants procedure. Laser fluorescent imaging represents an objective measurement technique that has been used for several years to monitor the vascularity of flaps used in breast reconstruction.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18 - 80
  • Consent for participation

排除标准

  • history of allergy to iodinated contrast dye -

结局指标

主要结局

Blood supply to breast as evaluated by laser fluorescent imaging

时间窗: 5 months

Laser fluorescent imaging is used to evaluate breast blood supply.

次要结局

未报告次要终点

研究者

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

Eric Swanson, M.D.

Principal Investigator

Swanson Center

研究点 (1)

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