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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
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.
participants did not receive intervention
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Recruitment Rate
Percent of eligible patients who consent
Time frame: through week 2
Protocol Adherence Rate
Percent of participants compliant with preconditioning as assigned
Time frame: through week 2
Interrater Reliability of Mastectomy Skin Flap Necrosis
consistency of flap necrosis diagnosis across independent surgeons
Time frame: through week 2
Interrater Reliability of SKIN Score
consistency of SKIN score across independent surgeons
Time frame: through week 2
Participant Feedback Survey Score
Participants will be given an 11-item questionnaire with total score range 11-55 with lower scores indicating higher level of satisfaction.
Time frame: through week 2
Incidence of Mastectomy Skin Flap Necrosis
number of participants with mastectomy skin flap necrosis
Time frame: through week 2
Severity of Mastectomy Skin Flap Necrosis
severity of mastectomy skin flap necrosis measured by SKIN score
Time frame: through week 2
Timing of Necrosis Onset
number of days until onset of postoperative necrosis
Time frame: through week 2
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Number of Intraoperative Deviations
Number of intraoperative deviation from planned reconstruction (e.g. aborted immediate reconstruction, expander deflation, closure over drains)
Time frame: through week 2
Number of Postoperative Wound Complications
Number of participants with postoperative wound complications (e.g., infection, incision dehiscence, flap erosion, expander exposure)
Time frame: through week 2
Number of Expander Failures
Number of participants with expander failure defined as explantation, loss, or non-use due to flap compromise
Time frame: through week 2
Number of Returns to the Operating Room
Number of participants that returned to the Operating Room due to necrosis or related complications
Time frame: through week 2
Length of Hospital Stay
number of days participants spent admitted to the hospital
Time frame: through week 2
Length of Follow Up
number of weeks participants were followed post discharge
Time frame: through week 2