RecruitingPhase 1NCT07264790

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

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


Sponsor

Duke University

Enrollment

25 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • Female sex > 18 years old
  • Genetic predisposition to cancer
  • Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction
  • Capable of giving informed consent

Exclusion Criteria4

  • Diagnosis of breast cancer
  • History of cancer
  • Currently pregnant or planning to be pregnant (for women of child-bearing potential)
  • Male sex

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Interventions

DRUGMinoxidil

Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery.

DRUGHair mousse

Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery.


Locations(1)

Duke Health

Durham, North Carolina, United States

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NCT07264790


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