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临床试验/NCT01789450
NCT01789450Unknown不适用

Nipple-Areola Complex Sensitivity After the Section of Periareolar Dermis in Breast Reduction

Universidade Federal de Pernambuco2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Nipple-Areola Complex (NAC) Sensitivity

研究概览

简要总结

The purpose of this study is to evaluate the feasibility and sensitivity of nipple-areolar complex (NAC) prospectively due to the section of the dermis after decortication (Schwartzmann's maneuver), in 50 patients undergoing breast reduction surgery.

详细描述

Preservation of the dermis after decortication regions of the areola and periareolar is considered relevant by most plastic surgeons.

In patients whose CAP should be mobilized through large distances in order to correct breast ptosis, or in cases of dense breasts where noted little slip of skin over the breast parenchyma, the periareolar dermis causes limitation on the mobility of the NAC.

In clinical practice, there is a greater mobilization of NAC when making a careful section of the dermis after decortication. In contrast, the appearance of partial necrosis in these cases has become a rarity, as no case of total necrosis was observed.

Given the technical benefit observed due to greater mobilization, there is no report in the literature about how behaves the sensitivity of the NAC in these cases.

To evaluate the sensitivity of the NAC will be used Semmes-Weisnstein's monofilament. Each point will be obtained five measurements. The largest will be scorned and the lowest value. The final value of each point corresponds to an arithmetic mean of the three remaining values.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients who willingly seek the service requesting breast reduction or mastopexy;
  • Patients who after consultation with the surgeon who led the research presents realistic expectation, being safe with the possible outcome of the surgery;
  • Patients who undertake to comply with the protocol previously presented and discussed with them;

排除标准

  • Patients with prior breast surgery;
  • Patients with body mass index (BMI) greater than 34.9;
  • Patients with severe anemia;
  • Patients with neurological disease;
  • Patients with impairment cardiovascular;
  • Metabolic diseases - diabetes;
  • Patients with autoimmune disease;
  • Menopausal patients
  • Patients with collagen disease;
  • Patients with psychiatric disorders.

结局指标

主要结局

Nipple-Areola Complex (NAC) Sensitivity

时间窗: 3 weeks

To evaluate the sensitivity of the NAC in breast reduction

次要结局

  • Nipple-Areola Complex (NAC) sensitivity(6 weeks)

研究者

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

Jairo Zacchê de Sá

Jairo Zacchê de Sá

Federal University of São Paulo

研究点 (2)

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