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