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临床试验/NCT03578484
NCT03578484进行中(未招募)不适用

Breast Aesthetics by Three Dimensional Measures - A Transatlantic Evaluation of Beauty Ideals Using 3D Scanning and Mammometrics.

Sykehuset Telemark2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2016年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
32
试验地点
2
主要终点
Breast aesthetic score in Scandinavia

研究概览

简要总结

Traditionally the measures of the optimally aesthetic breast have been assumed to be static and to represent universal values (1). Measures developed for optimal aesthetic results in breast reduction were derived from brassiere patterns and then applied universally (2). These early and important papers still strongly influence the view of the aesthetics of the breast despite the lack of individualisation and proportion.

To create satisfying results for specific patients, optimal proportions angles and relative measures are needed for each patient. The study will clarify theses measures and provide important guidelines for surgeons.The data will also help define optimal proportional aesthetics in the individual patient.

The concept of universal beauty is unrealistic. It has always been taken for granted that aesthetic values from all cultures are similar. Using 3D scanning on volunteers of youthful age offers a complex set of data that may distinguish fine differences in aesthetic ideals in different cultures.

Little is known about how life events and life-style factors affect breast aesthetics.

To follow a population with 3D scans over 5, 10 and 15 years will allow aesthetic ratings to be correlated with life events such as pregnancy, childbirth, breast-feeding and life style factors such as smoking.

The study will improve the understanding of breast aesthetics in general, in different cultures and in relation to life events and life style factors. No similar studies have previously been performed.

详细描述

Aims for the study:

To identify aesthetic factors that contribute to overall beauty and aesthetics of the breast.

To identify proportions and measures of the most aesthetically pleasing breast and also of the least appealing breast. This will provide a guideline and a map for the reconstructive breast surgeon in what to aim for and what to avoid in the breast reconstructive process.

To identify cultural differences in the perception of beauty.

Aims for the longitudinal part of the study:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • The study will be based on female volunteers between the ages of 18 and 35 of all ethnic backgrounds.

排除标准

  • Patients with breast cancer treatment, removal of non-malignant masses, trauma, burns or dermatological diagnoses involving the breast are excluded from the study.

结局指标

主要结局

Breast aesthetic score in Scandinavia

时间窗: 5 years

Using a rating system developed by Sandberg and Selber for this project, each individual breast (left and right) will be scored according to aesthetic aspects. A score ranging from 1 lowest to 5 highest will be given by the rater. The parameters rated will be breast size, breast width, breast height, breast position, nipple position, nipple shape, nipple color and breast shape. The score will be the outcome measure for the most pleasant aesthetics.

Breast measures in centimeters and degrees in USA

时间窗: 5 years

The highest and lowest scored breasts will be measured. Anatomic measures of the breast between fiduciary points, such as distance the nipple and the sternal notch in centimeters. Also measures of angles between the midline and nipple position measured in degrees. Also measures of curvatures in degrees and vectors. The measures will be performed digitally on the 3D scans obtained by the Vectra system for 3D scanning using the software developed by Canfield Inc. This will be the outcome measure in centimeters, degrees and proportions for USA.

Breast measures in centimeters and degrees in Scandinavia

时间窗: 5 years

The highest and lowest scored breasts will be measured. Anatomic measures of the breast between fiduciary points, such as distance the nipple and the sternal notch in centimeters. Also measures of angles between the midline and nipple position measured in degrees. Also measures of curvatures in degrees and vectors. The measures will be performed digitally on the 3D scans obtained by the Vectra system for 3D scanning using the software developed by Canfield Inc. This will be the outcome measure in centimeters, degrees and proportions.

Breast aesthetic score in USA

时间窗: 5 years

Using a rating system developed by Sandberg and Selber for this project, each individual breast (left and right) will be scored according to aesthetic aspects. A score ranging from 1 lowest to 5 highest will be given by the rater. The parameters rated will be breast size, breast width, breast height, breast position, nipple position, nipple shape, nipple color and breast shape. The score will be the outcome measure for the most pleasant aesthetics in the USA.

次要结局

  • Change in breast aesthetic score at 5 years(10 years)
  • Breast measures in centimeters and degrees changes at 5 years(10 years)
  • Breast measures in centimeters and degrees changes at 10 years(15 years)
  • Change in breast aesthetic score at 10 years(15 years)
  • Breast measures in centimeters and degrees changes at 15 years(16 years)
  • Change in breast aesthetic score at 15 years(16 years)

研究者

发起方
Sykehuset Telemark
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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