Duke Health
Durham, North Carolina, 27710, United States
Location status: Recruiting
NCT Number: NCT07264790
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 1
Durham, North Carolina, 27710, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery.
Each participant will receive both topical agents in order to apply daily for 14-days prior to surgery.
Time frame: Day 1
Rate of study participation from eligible patients undergoing bilateral risk-reducing mastectomy with tissue expander-based implant reconstruction
Time frame: 90 days
Retention of enrolled participants until the clinical endpoint
Time frame: 90 days
Rate of adherence to the treatment protocol
Time frame: 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.
Time frame: Day of surgery
Perfusion is assessed using "relative value," which quantifies fluorescence as a percentage (%) relative to a reference point.
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Contact information is provided by the study sponsor or research team.
Duke University
Other
Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Reconstruction
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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