NCT07516483

Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Breast Reconstruction After Mastectomy

Interventions

Type	Name	Description
OTHER	1 Cycle Thermal Preconditioning	Thermal preconditioning with Plexaa BLOOM43 starting as close to 1 hour before the surgery as possible. Participants will keep the device on the breast for a total of 1 hour, allowing completion of one heating-cooling cycle before removing and turning off the device.
OTHER	3 Cycles Thermal Preconditioning	Thermal preconditioning with Plexaa BLOOM43 as close to 12 hours before the scheduled operation as possible. Participants will use the device as programmed, keeping it on the breast for a total of 3 hours.
OTHER	No Intervention	participants did not receive intervention

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States