Study of Topical Minoxidil to Improve Flap Blood Flow and Skin Survival During Breast Reconstruction Surgery After Preventive Mastectomy

What this Trial Is About

Researchers are evaluating whether applying topical minoxidil before surgery can improve blood flow and skin flap health in women undergoing bilateral risk-reducing mastectomy with reconstruction. This phase 1 trial uses a triple-blind design where each participants breasts are randomized to receive either minoxidil or a placebo to compare outcomes within the same patient. Participants will apply two different solutions daily5% minoxidil to one breast and a placebo hair mousse to the otherfor 14 days prior to their scheduled surgery. Surgery then proceeds as usual without changes to standard care. This approach allows direct comparison of flap perfusion and viability between the treated and control breast during reconstruction. Throughout the study, researchers will measure feasibility by recruitment, retention, and adherence rates. On the day of surgery, flap perfusion will be assessed by a blinded plastic surgeon and via ICG angiography. Safety outcomes such as skin flap necrosis, surgical complications, and need for further surgeries will be monitored up to 90 days post-surgery. Total participation lasts until 90 days after the operation.

Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Recon