Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Reconstruction After Mastectomy
• Intervention / Treatment: Other: 3 Cycles Thermal Preconditioning; Other: 1 Cycle Thermal Preconditioning; Other: No Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caleb Suggs; Phone Number: 3367134339; Email: caleb.suggs@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 or comply with study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 Preconditioning Cycles; three cycles of alternating between 30 minutes heating and 30 minutes spontaneous cooling to the breast 12 hours before operation.	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.
Experimental: 1 Preconditioning Cycle; one cycle of alternating between 30 minutes heating and 30 minutes cooling in the preoperative area 1 hour before operation.	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.
Active Comparator: Retrospective Group; retrospective chart review of patients meeting the same eligibility criteria who did not receive prospective interventions	Other: No Intervention; participants did not receive intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rate	Percent of eligible patients who consent	through week 2
Protocol Adherence Rate	Percent of participants compliant with preconditioning as assigned	through week 2
Interrater Reliability of Mastectomy Skin Flap Necrosis	consistency of flap necrosis diagnosis across independent surgeons	through week 2
Interrater Reliability of SKIN Score	consistency of SKIN score across independent surgeons	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.	through week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Mastectomy Skin Flap Necrosis	number of participants with mastectomy skin flap necrosis	through week 2
Severity of Mastectomy Skin Flap Necrosis	severity of mastectomy skin flap necrosis measured by SKIN score	through week 2
Timing of Necrosis Onset	number of days until onset of postoperative necrosis	through week 2
Number of Intraoperative Deviations	Number of intraoperative deviation from planned reconstruction (e.g. aborted immediate reconstruction, expander deflation, closure over drains)	through week 2
Number of Postoperative Wound Complications	Number of participants with postoperative wound complications (e.g., infection, incision dehiscence, flap erosion, expander exposure)	through week 2
Number of Expander Failures	Number of participants with expander failure defined as explantation, loss, or non-use due to flap compromise	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	through week 2
Length of Hospital Stay	number of days participants spent admitted to the hospital	through week 2
Length of Follow Up	number of weeks participants were followed post discharge	through week 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data Completeness Rate	Percent of planned outcome data collected	through week 2
Blinding Success Rate	number of surgeons that remained unaware of allocation during image-based diagnosis and grading of necrosis	through week 2
Use of Indocyanine Green Angiography	number of surgeons that used indocyanine green angiography	through week 2
Change from preoperative plan to final operation	number of surgeons that changed their preoperative plan before the final operation	through week 2

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Adam Katz, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: breast reconstruction; mastectomy; heat preconditioning
• Other Study ID Numbers: IRB00146716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No