Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up Women only

Topical 5% minoxidil to boost blood flow and skin‑flap survival during breast reconstruction

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

Run by Duke University · NCT07264790 · Data updated 2026-11-12

This trial will test whether applying 5% topical minoxidil to one breast before bilateral risk‑reducing mastectomy with immediate reconstruction improves blood flow and skin‑flap survival compared with a placebo on the other breast.

More Genetic Predisposition trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment25 (estimated)
SponsorDuke University
Academic / other
Locations1 site (Durham, North Carolina)
StatusRecruiting
StartedMarch 16, 2026
Main results expectedSeptember 2027
Study endsSeptember 2027
Registry record updatedJuly 8, 2026
Trial IDNCT07264790 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adult women over 18 with a genetic predisposition who are planning bilateral prophylactic mastectomy with immediate reconstruction and can give informed consent.

Probably not a fit

Patients with an active or prior diagnosis of cancer, males, pregnant women, or those not undergoing bilateral prophylactic mastectomy are not eligible and would not receive benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, within‑patient randomized, triple‑blind trial enrolls women with a genetic predisposition undergoing bilateral prophylactic mastectomy with same‑day reconstruction. Each participant will apply an assigned compound (minoxidil or placebo) to one breast per pharmacy directions prior to surgery, with the opposite breast serving as the internal control. Intraoperative measurements of flap perfusion and postoperative flap viability will be compared between the treated and placebo breasts. The design uses randomization by breast and blinding of participants, surgeons, and outcome assessors to limit bias.

Why it matters

Potential benefit: If successful, this approach could increase flap perfusion and reduce ischemic complications, decreasing the rate of flap necrosis and need for revision surgery.

How similar studies have gone: This use of topical minoxidil as a preoperative pharmacologic delay is novel in human breast reconstruction, though other vasodilator or delay strategies have been explored in small or preclinical studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Duke Health
    Durham, North Carolina, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.