Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Recon
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Minoxidil, Hair mousse.
- Who it may be relevant to
- Registry conditions: Breast Reconstruction, Perfusion; Complications, High Risk for Breast Cancer, Genetic Predisposition. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Reconstruction
Overview
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]
- Feasibility, as measured by retention rate [Time frame: 90 days]
- Feasibility, as measured by rate of participant adherence to the protocol [Time frame: 90 days]
Secondary outcome measures (5)
- Flap perfusion, assessed by a blinded plastic surgeon [Time frame: Day of surgery]
- Flap perfusion, assessed by ICG angiography [Time frame: Day of surgery]
- Incidence of mastectomy skin flap necrosis [Time frame: 90 days]
- Incidence of surgical complications [Time frame: 90 days]
- Incidence of reoperations or definitive second-stage reconstruction [Time frame: 90 days]
Eligibility criteria
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)
- Male sex
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke Health — Durham
Identifiers
NCT: NCT07264790 · Pro00116354