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RECRUITING
NCT07264790
PHASE1

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

Sponsor: Duke University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2026-04

Completion Date

2027-09

Last Updated

2026-04-06

Healthy Volunteers

No

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.

Locations (1)

Duke Health

Durham, North Carolina, United States