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NCT Number: NCT07516483

Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction

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.

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Key information

Conditions

Breast Reconstruction After Mastectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Recruitment Rate

    Time frame: through week 2

    Percent of eligible patients who consent

  2. Protocol Adherence Rate

    Time frame: through week 2

    Percent of participants compliant with preconditioning as assigned

  3. Interrater Reliability of Mastectomy Skin Flap Necrosis

    Time frame: through week 2

    consistency of flap necrosis diagnosis across independent surgeons

  4. Interrater Reliability of SKIN Score

    Time frame: through week 2

    consistency of SKIN score across independent surgeons

  5. Participant Feedback Survey Score

    Time frame: through week 2

    Participants will be given an 11-item questionnaire with total score range 11-55 with lower scores indicating higher level of satisfaction.

Secondary outcomes

  1. Incidence of Mastectomy Skin Flap Necrosis

    Time frame: through week 2

    number of participants with mastectomy skin flap necrosis

  2. Severity of Mastectomy Skin Flap Necrosis

    Time frame: through week 2

    severity of mastectomy skin flap necrosis measured by SKIN score

  3. Timing of Necrosis Onset

    Time frame: through week 2

    number of days until onset of postoperative necrosis

  4. Number of Intraoperative Deviations

    Time frame: through week 2

    Number of intraoperative deviation from planned reconstruction (e.g. aborted immediate reconstruction, expander deflation, closure over drains)

  5. Number of Postoperative Wound Complications

    Time frame: through week 2

    Number of participants with postoperative wound complications (e.g., infection, incision dehiscence, flap erosion, expander exposure)

  6. Number of Expander Failures

    Time frame: through week 2

    Number of participants with expander failure defined as explantation, loss, or non-use due to flap compromise

  7. Number of Returns to the Operating Room

    Time frame: through week 2

    Number of participants that returned to the Operating Room due to necrosis or related complications

  8. Length of Hospital Stay

    Time frame: through week 2

    number of days participants spent admitted to the hospital

  9. Length of Follow Up

    Time frame: through week 2

    number of weeks participants were followed post discharge

Other outcomes

  1. Data Completeness Rate

    Time frame: through week 2

    Percent of planned outcome data collected

  2. Blinding Success Rate

    Time frame: through week 2

    number of surgeons that remained unaware of allocation during image-based diagnosis and grading of necrosis

  3. Use of Indocyanine Green Angiography

    Time frame: through week 2

    number of surgeons that used indocyanine green angiography

  4. Change from preoperative plan to final operation

    Time frame: through week 2

    number of surgeons that changed their preoperative plan before the final operation

Study contacts

Contact information is provided by the study sponsor or research team.

Caleb Suggs

CONTACT

[email protected]

3367134339

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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