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临床试验/NCT03376035
NCT03376035已完成不适用

Pilot Study Assessing Cutaneous Breast Temperature in the Setting of Mastectomy and Reconstruction

Duke University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年12月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
2
主要终点
Change in skin temperature after breast reconstruction

研究概览

简要总结

Our investigators plan to measure the skin on the breast six months after breast reconstruction. The non-reconstructed breast will be used as the control for subject with unilateral reconstruction only. For those who have BILATERAL reconstruction, a core temperature will be obtained from the ear.

详细描述

Many factors influence outcomes following mastectomy and breast reconstruction. Cutaneous sensation, degree of scar formation, nipple projection and overall appearance are well correlated with patient satisfaction. However, very little data exists on the importance of skin temperature after mastectomy and reconstruction. Our investigators have noted that a number of patients report their reconstructed breast is cold and relate this as a source of dis-satisfaction. In these patients, it is unclear if 1) the reconstructed breast skin is cold and if so 2) can something can be done to improve this. Our investigators hypothesize that cutaneous breast temperature may be altered after mastectomy and reconstruction. This may be dependent on the reconstruction technique and other patient factors. In this pilot study, our investigators aim to establish techniques for evaluating cutaneous breast temperature following mastectomy and reconstruction. Our investigators hope to establish baseline data to develop an understanding of breast skin temperature after mastectomy and reconstruction.

Our long-term goals are to evaluate how cutaneous breast temperature may contribute to patient satisfaction. Our investigators also hope to determine which patients are at risk for developing a cold breast after surgery. Finally, our investigators will setup a prospective trial evaluating techniques to correct this problem and improve patient satisfaction.

研究设计

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

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • For post-reconstruction patients: all patients who have undergone mastectomy and breast reconstruction at Duke and are seen in clinic no sooner than 3 months after reconstruction and no more than 5 years after reconstruction.

排除标准

  • Metastatic malignancy of any kind.
  • Subjects with a history of breast implant augmentation prior to mastectomy and reconstruction.
  • Subjects who cannot give an informed consent.

研究组 & 干预措施

Unilateral breast reconstruction

Active Comparator

Temperature measurements are obtained from the reconstructed breast and compared to the non-reconstructed breast.

干预措施: Temperature measurement of breast (Other)

Bilateral breast reconstruction

Experimental

Temperature measurements are obtained from both reconstructed breasts and the core temperature is measured as well for comparison.

干预措施: Temperature measurement of breast (Other)

结局指标

主要结局

Change in skin temperature after breast reconstruction

时间窗: 6 months after surgery

Temperature measurements

次要结局

未报告次要终点

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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