Thermal Preconditioning in Patients Undergoing Mastectomy With Planned Immediate Breast Reconstruction: A Randomized Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
The purpose of this research study is to understand patient experiences and the feasibility of using a breast heat preconditioning device (Plexaa BLOOM43), designed to improve postoperative outcomes when used prior to mastectomy and breast reconstruction.
详细描述
This study will be a prospective, single-center, two-arm randomized trial comparing two preconditioning interventions, with a separate retrospective cohort serving as the standard of care control group without preconditioning. For the prospective component, eligible patients undergoing mastectomy with preoperative plan of undergoing immediate autologous or device-based breast reconstruction at the Atrium Health Wake Forest Baptist Medical Center will be randomized in a 1:1 ratio into a 3-cycle or 1-cycle treatment group. There will also be a retrospective chart review to create a control group.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years of age) undergoing prophylactic or therapeutic mastectomy with planned immediate breast reconstruction at Atrium Health Wake Forest Baptist Medical Center.
排除标准
- •Patients with no plan for any breast reconstruction.
- •Patients with inflammatory breast cancer.
- •History of any radiation to the breast or chest wall.
- •Patients with pre-existing local dermatological conditions.
- •Patients belonging to vulnerable populations (e.g., children, pregnant individuals, incarcerated persons).
- •Patients unable to provide informed consent or comply with study procedures.
研究组 & 干预措施
3 Preconditioning Cycles
three cycles of alternating between 30 minutes heating and 30 minutes spontaneous cooling to the breast 12 hours before operation.
干预措施: 3 Cycles Thermal Preconditioning (Other)
1 Preconditioning Cycle
one cycle of alternating between 30 minutes heating and 30 minutes cooling in the preoperative area 1 hour before operation.
干预措施: 1 Cycle Thermal Preconditioning (Other)
Retrospective Group
retrospective chart review of patients meeting the same eligibility criteria who did not receive prospective interventions
干预措施: No Intervention (Other)
结局指标
主要结局
Recruitment Rate
时间窗: through week 2
Percent of eligible patients who consent
Protocol Adherence Rate
时间窗: through week 2
Percent of participants compliant with preconditioning as assigned
Interrater Reliability of Mastectomy Skin Flap Necrosis
时间窗: through week 2
consistency of flap necrosis diagnosis across independent surgeons
Interrater Reliability of SKIN Score
时间窗: through week 2
consistency of SKIN score across independent surgeons
Participant Feedback Survey Score
时间窗: through week 2
Participants will be given an 11-item questionnaire with total score range 11-55 with lower scores indicating higher level of satisfaction.
次要结局
- Incidence of Mastectomy Skin Flap Necrosis(through week 2)
- Severity of Mastectomy Skin Flap Necrosis(through week 2)
- Timing of Necrosis Onset(through week 2)
- Number of Intraoperative Deviations(through week 2)
- Number of Postoperative Wound Complications(through week 2)
- Number of Expander Failures(through week 2)
- Number of Returns to the Operating Room(through week 2)
- Length of Hospital Stay(through week 2)
- Length of Follow Up(through week 2)