Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction

Wake Forest University (WFU)

Status: Begins enrollment this month

Conditions: Breast Reconstruction After Mastectomy

Treatments: Other: 1 Cycle Thermal Preconditioning; Other: 3 Cycles Thermal Preconditioning; Other: No Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07516483

IRB00146716

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

3 Preconditioning Cycles

Experimental group

Description:

three cycles of alternating between 30 minutes heating and 30 minutes spontaneous cooling to the breast 12 hours before operation.

Treatment:

Other: 3 Cycles Thermal Preconditioning

1 Preconditioning Cycle

Experimental group

Description:

one cycle of alternating between 30 minutes heating and 30 minutes cooling in the preoperative area 1 hour before operation.

Treatment:

Other: 1 Cycle Thermal Preconditioning

Retrospective Group

Active Comparator group

Description:

retrospective chart review of patients meeting the same eligibility criteria who did not receive prospective interventions

Treatment:

Other: No Intervention