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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

Qualifiers

Female sex > 18 years old

Genetic predisposition to cancer

Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction

Capable of giving informed consent

Disqualifiers

Diagnosis of breast cancer

History of cancer

Currently pregnant or planning to be pregnant (for women of child-bearing potential)

Male sex

Trial design

Treatments tested in this trial

  • Minoxidil
  • Hair mousse

Treatment groups

25 Participants
are divided into 2 treatment groups

Sponsors and collaborators