Actively Recruiting

Phase 1
Age: 18Years +
FEMALE
NCT07264790

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

Led by Duke University · Updated on 2026-04-06

25

Participants Needed

1

Research Sites

74 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female sex over 18 years old
  • Genetic predisposition to cancer
  • Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction
  • Capable of giving informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Duke Health

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

J

Jennifer Gallagher

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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