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临床试验/NCT02464982
NCT02464982已完成不适用

Areola Tattoo: the End of a Long Therapeutic Process. A Patient's Quality of Life Dedicated Technology

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
107
试验地点
1
主要终点
Patient's satisfaction degree with qualitative questionnaire about them areola tattoo realized after surgery as part of breast cancer treatment

研究概览

简要总结

Mammary reconstruction replaces total skin transplant, which may causing patient discomfort. It is a simple, painless and reproductible technology that avoids consequences and complications related to transplant. Tattoo helps patients to return faster to the normal life and close more easily the cancer episode.

The study purpose is to measure the patient's esthetic satisfaction degree on 1year areola tattoo realized following standard care.

详细描述

Tattoo is realized as standard car as part of mammary reconstruction after surgery of patient suffering from breast cancer. We try to measured :

  • Tattooed patient's satisfaction degree with qualitative questionnaire using four level satisfaction scale (very satisfied, satisfied, dissatisfied, very dissatisfied)
  • Evaluate from patient and jury, the tall, form, color and areola position defects
  • Evaluate professional jury's satisfaction degree regarding this areola tattoo technology, with the same patient criteria

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • technology areola tattoo realized as part of 1 breast mammary reconstruction following an operated breast cancer

排除标准

  • Two breasts operated patient
  • surgical reconstruction

结局指标

主要结局

Patient's satisfaction degree with qualitative questionnaire about them areola tattoo realized after surgery as part of breast cancer treatment

时间窗: 1 year after areola tattoo have been realized following standard care

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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