Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07516483
Status
Not Yet Recruiting

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Conditions

  • Breast Reconstruction After Mastectomy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 1 Cycle Thermal Preconditioning — OTHER
    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 — OTHER
    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 — OTHER
    participants did not receive intervention

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 3 Preconditioning Cycles
    three cycles of alternating between 30 minutes heating and 30 minutes spontaneous cooling to the breast 12 hours before operation.
  • Experimental: 1 Preconditioning Cycle
    one cycle of alternating between 30 minutes heating and 30 minutes cooling in the preoperative area 1 hour before operation.
  • Active Comparator: Retrospective Group
    retrospective chart review of patients meeting the same eligibility criteria who did not receive prospective interventions

Primary Outcome Measure

Recruitment Rate [ Time Frame: through week 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-

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Wake Forest University Health Sciences· Winston-Salem, NC