Thermal Preconditioning in Patients Undergoing Mastectomy With Planned Immediate Breast Reconstruction: A Randomized Feasibility Trial
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Other1 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.
- Other3 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.
- OtherNo Intervention
participants did not receive intervention
Location
- Wake Forest University Health SciencesWinston-Salem, North Carolina