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Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction
Sponsor: Wake Forest University Health Sciences
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.
Official title: Thermal Preconditioning in Patients Undergoing Mastectomy With Planned Immediate Breast Reconstruction: A Randomized Feasibility Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-05
Completion Date
2027-05
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
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.
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.
No Intervention
participants did not receive intervention
Locations (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States