NCT07264790 · Duke University
Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Recon
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Minoxidil
Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery.
DRUG
Hair mousse
Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery.
Primary outcome measures
Feasibility, as measured by recruitment rate
Time frame: 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
Time frame: 90 days
Retention of enrolled participants until the clinical endpoint
Feasibility, as measured by rate of participant adherence to the protocol
Time frame: 90 days
Rate of adherence to the treatment protocol
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Female sex \> 18 years old
- Genetic predisposition to cancer
- Undergoing bilateral prophylactic mastectomy with same-day breast reconstruction
- Capable of giving informed consent
Exclusion criteria
- Diagnosis of breast cancer
- History of cancer
- Currently pregnant or planning to be pregnant (for women of child-bearing potential)
Where
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations