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NCT07264790PHASE1Recruiting

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

Duke University

Start Date

3/16/2026

Completion Date

9/1/2027

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Female sex \> 18 years old 2. Genetic predisposition to cancer 3. Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction 4. Capable of giving informed consent Exclusion Criteria: 1. Diagnosis of breast cancer 2. History of cancer 3. Currently pregnant or planning to be pregnant (for women of child-bearing potential) 4. Male sex

Interventions

DRUG

Minoxidil

DRUG

Hair mousse

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Conditions

Breast ReconstructionPerfusion; ComplicationsHigh Risk for Breast CancerGenetic Predisposition

Locations

Duke Health

Durham, North Carolina 27710

United States