Topical 5% minoxidil to boost blood flow and skin‑flap survival during breast reconstruction
Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Reconstruction
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 |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT07264790 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Durham, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.