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

NCT07264790 — Phase 1, Recruiting, 25 participants, Duke University

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

Registry	NCT07264790
Status	Recruiting
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	25 (Estimated)
Sponsor	Duke University (Other)
Conditions	Breast Reconstruction, Perfusion; Complications, High Risk for Breast Cancer, Genetic Predisposition
Interventions	Minoxidil, Hair mousse (Drug)
Dates	start 2026-03-16, primary completion 2027-09-01 (estimated), completion 2027-09-01 (estimated), first posted 2025-12-04, last updated 2026-07-08
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Minoxidil	Experimental	Drug: Minoxidil	All participants in this study will receive two solutions at a pre-operative visit: study drug and placebo. Use of the solutions will be randomized which means participants will be instructed to apply one solution to one breast and the other solution to the other breast.
Hair mousse	Placebo comparator	Drug: Hair mousse	All participants in this study will receive two solutions at a pre-operative visit: study drug and placebo. Use of the solutions will be randomized which means participants will be instructed to apply one solution to one breast and the other solution to the other breast.

Minoxidil (Drug): Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery.
Hair mousse (Drug): Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery.

+Outcome measures

Primary outcomes

Feasibility, as measured by recruitment rate [Day 1]: Rate of study participation from eligible patients undergoing bilateral risk-reducing mastectomy with tissue expander-based implant reconstruction
Feasibility, as measured by retention rate [90 days]: Retention of enrolled participants until the clinical endpoint
Feasibility, as measured by rate of participant adherence to the protocol [90 days]: Rate of adherence to the treatment protocol

Secondary outcomes

Flap perfusion, assessed by a blinded plastic surgeon [Day of surgery]: A third-party blinded plastic surgeon will visually evaluate flap perfusion, from preoperative and intraoperative photos, and SPY-QP video and use their clinical judgement to assess perfusion.
Flap perfusion, assessed by ICG angiography [Day of surgery]: Perfusion is assessed using "relative value," which quantifies fluorescence as a percentage (%) relative to a reference point.
Incidence of mastectomy skin flap necrosis [90 days]
Incidence of surgical complications [90 days]
Incidence of reoperations or definitive second-stage reconstruction [90 days]

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Duke Health	Durham, North Carolina	United States	Recruiting

+Investigators

Brett Phillips, MD, Principal investigator, Duke University