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

What this Trial Is About

Researchers are evaluating whether applying a medication called minoxidil before surgery can improve blood flow and skin flap health during breast reconstruction after bilateral risk-reducing mastectomy in women with a genetic risk for breast cancer. This Phase 1 study compares minoxidil with a placebo to see if the treatment can enhance flap viability at the time of surgery. The trial is triple-blinded, meaning neither the participants nor the investigators know which breast receives minoxidil. Each participant will apply two topical solutions, minoxidil and a placebo hair mousse, one to each breast for 14 days before surgery. The assignment of which breast receives minoxidil or placebo is randomized. Surgery proceeds as usual, without changes to standard procedures. This design allows direct comparison of minoxidil's effects on one breast against the placebo on the other. Participants will be monitored for recruitment, retention, and adherence rates as primary outcomes. Secondary outcomes include flap blood flow assessed during surgery by a plastic surgeon and imaging, occurrence of skin flap necrosis, surgical complications, and any need for additional surgeries within 90 days. The total study duration includes follow-up for 90 days after surgery to assess these outcomes.

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