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.
Female sex > 18 years old
Genetic predisposition to cancer
Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction
Capable of giving informed consent
Diagnosis of breast cancer
History of cancer
Currently pregnant or planning to be pregnant (for women of child-bearing potential)
Male sex
Parallel
Minoxidil
DrugEach participant will receive both topical agents in order to apply daily for 14-days prior to surgery.
Hair mousse
DrugEach participant will receive both topical agents in order to apply daily for 14-days prior to surgery.
Feasibility, as measured by recruitment rate
Rate of study participation from eligible patients undergoing bilateral risk-reducing mastectomy with tissue expander-based implant reconstruction
Feasibility, as measured by retention rate
Retention of enrolled participants until the clinical endpoint
Feasibility, as measured by rate of participant adherence to the protocol
Rate of adherence to the treatment protocol
Flap perfusion, assessed by a blinded plastic surgeon
A third-party blinded plastic surgeon will visually evaluate flap perfusion, from preoperative and intraoperative photos, and SPY-QP video and use their clinical judgement to assess perfusion.
Flap perfusion, assessed by ICG angiography
Perfusion is assessed using "relative value," which quantifies fluorescence as a percentage (%) relative to a reference point.
Incidence of mastectomy skin flap necrosis
Incidence of surgical complications
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