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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07264790
Phase
PHASE1
Status
Recruiting
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Conditions

  • Breast Reconstruction
  • Genetic Predisposition
  • High Risk for Breast Cancer
  • Perfusion; Complications

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

Feasibility, as measured by recruitment rate [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke HealthDurhamNorth Carolina27710
Jennifer Gallagher, BA
[email protected]

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By research site
Duke Health· Durham, NC

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