Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction

Thermal Preconditioning in Patients Undergoing Mastectomy With Planned Immediate Breast Reconstruction: A Randomized Feasibility Trial

The purpose of this research study is to understand patient experiences and the feasibility of using a breast heat preconditioning device (Plexaa BLOOM43), designed to improve postoperative outcomes when used prior to mastectomy and breast reconstruction.

This study will be a prospective, single-center, two-arm randomized trial comparing two preconditioning interventions, with a separate retrospective cohort serving as the standard of care control group without preconditioning. For the prospective component, eligible patients undergoing mastectomy with preoperative plan of undergoing immediate autologous or device-based breast reconstruction at the Atrium Health Wake Forest Baptist Medical Center will be randomized in a 1:1 ratio into a 3-cycle or 1-cycle treatment group. There will also be a retrospective chart review to create a control group.

Inclusion Criteria:

• Adult patients (≥ 18 years of age) undergoing prophylactic or therapeutic mastectomy with planned immediate breast reconstruction at Atrium Health Wake Forest Baptist Medical Center.

Exclusion Criteria:

• Patients with no plan for any breast reconstruction.
• Patients with inflammatory breast cancer.
• History of any radiation to the breast or chest wall.
• Patients with pre-existing local dermatological conditions.
• Patients belonging to vulnerable populations (e.g., children, pregnant individuals, incarcerated persons).
• Patients unable to provide informed consent or comply with study procedures.