Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Reconstruction
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Feasibility, as measured by recruitment rate
研究概览
简要总结
The purpose of the study is to determine whether pharmacologic delay using minoxidil in patients undergoing bilateral risk reducing mastectomy with reconstruction could achieve improvement in flap perfusion and flap viability at the time of surgery. Patients will undergo randomization of their breasts to determine which breast will receive the experimental intervention and which breast will serve as the internal control (receive placebo). The experimental breast will receive the novel pharmacologic delay treatment, 5% minoxidil, while the internal control breast will receive the current standard of care, which does not include any topical application prior to surgery - a placebo control will be used.
This will be a triple-blind study, where both the participants and investigators will be blinded to which breast will receive the intervention. The patients will receive two bottles "compound A" and "compound B" with directions from the pharmacy for which compound to apply to each breast.
Product will be applied for 2 weeks prior to planned surgery. Surgery will proceed without any changes to standard practice.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Female sex > 18 years old
- •Genetic predisposition to cancer
- •Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction
- •Capable of giving informed consent
排除标准
- •Diagnosis of breast cancer
- •History of cancer
- •Currently pregnant or planning to be pregnant (for women of child-bearing potential)
研究组 & 干预措施
Hair mousse
All participants in this study will receive two solutions at a pre-operative visit: study drug and placebo. Use of the solutions will be randomized which means participants will be instructed to apply one solution to one breast and the other solution to the other breast.
干预措施: Hair mousse (Drug)
Minoxidil
All participants in this study will receive two solutions at a pre-operative visit: study drug and placebo. Use of the solutions will be randomized which means participants will be instructed to apply one solution to one breast and the other solution to the other breast.
干预措施: Minoxidil (Drug)
结局指标
主要结局
Feasibility, as measured by recruitment rate
时间窗: Day 1
Rate of study participation from eligible patients undergoing bilateral risk-reducing mastectomy with tissue expander-based implant reconstruction
Feasibility, as measured by retention rate
时间窗: 90 days
Retention of enrolled participants until the clinical endpoint
Feasibility, as measured by rate of participant adherence to the protocol
时间窗: 90 days
Rate of adherence to the treatment protocol
次要结局
- Flap perfusion, assessed by a blinded plastic surgeon(Day of surgery)
- Flap perfusion, assessed by ICG angiography(Day of surgery)
- Incidence of mastectomy skin flap necrosis(90 days)
- Incidence of surgical complications(90 days)
- Incidence of reoperations or definitive second-stage reconstruction(90 days)