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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 25 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | March 16, 2026 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT07264790 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
- Principal investigator: Brett Phillips, MD — Duke University
- Study coordinator: Jennifer Gallagher
- Email: jennifer.gallagher@duke.edu
- Phone: 9199701551
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.