Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07264790

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Duke Health

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Jennifer Gallagher, BA

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. Feasibility, as measured by retention rate

    Time frame: 90 days

    Retention of enrolled participants until the clinical endpoint

  3. Feasibility, as measured by rate of participant adherence to the protocol

    Time frame: 90 days

    Rate of adherence to the treatment protocol

Secondary outcomes

  1. Flap perfusion, assessed by a blinded plastic surgeon

    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.

  2. Flap perfusion, assessed by ICG angiography

    Time frame: Day of surgery

    Perfusion is assessed using "relative value," which quantifies fluorescence as a percentage (%) relative to a reference point.

  3. Incidence of mastectomy skin flap necrosis

    Time frame: 90 days

  4. Incidence of surgical complications

    Time frame: 90 days

  5. Incidence of reoperations or definitive second-stage reconstruction

    Time frame: 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Gallagher

CONTACT

[email protected]

9199701551

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 4, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.