Mastectomy Flap Temperature and Clinical Implications
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery
研究概览
简要总结
The purpose of this research study is to measure tissue temperatures and generate a prospective database of participants undergoing mastectomy with or without breast reconstruction at Wake Forest Baptist Hospital (WFBH) in order to enable and facilitate the evaluation of important and novel research questions - and quality improvement (QI) ideas/objectives - that may improve the care of breast surgery patients.
详细描述
Primary Objective(s)
- Quantify the proportion of eligible women approached who consent to intraoperative (pre and post mastectomy) measurement of mastectomy flap temperatures in each of 4 quadrants of each relevant breast (i.e., unilateral or bilateral procedure).
- Quantify the proportion of patients upon whom the surgical team is able to obtain intraoperative flap measurements from each of 4 quadrants on each relevant breast pre- and post-mastectomy and pre-implant.
Secondary Objective: To measure mastectomy flap temperatures in 4 quadrants pre-mastectomy, following mastectomy, and pre-implant, and compare average flap temperature to average core body temperature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled for unilateral or bilateral mastectomy with implant based breast reconstruction within the Wake Forest Baptist Health System.
- •Aged 18 or older.
- •Ability to understand an IRB-approved informed consent document (either directly or via a legally authorized representative).
排除标准
- •Those who are male.
结局指标
主要结局
Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery
时间窗: 90 days post surgery
This will be computed by the dividing the total number of eligible women screened by the number of women who consent.
Number of Women Having All Relevant Flap Temperatures Measured
时间窗: 90 days post surgery
This will either be 12 or 24 total expected flap temperatures: 4 quadrants, at three time points- pre and post-mastectomy and pre-implant placement; one or both breasts), and we will compute a 95% confidence interval.
次要结局
- Change in Mastectomy Flap Temperatures and Core Body Temperatures(At pre-mastectomy (baseline), pre-implant (before surgery) and post mastectomy (up to 90 days post surgery))