Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction

August 24, 2026 updated by: Wake Forest University Health Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: through week 2
Percent of eligible patients who consent
through week 2
Protocol Adherence Rate
Time Frame: through week 2
Percent of participants compliant with preconditioning as assigned
through week 2
Interrater Reliability of Mastectomy Skin Flap Necrosis
Time Frame: through week 2
consistency of flap necrosis diagnosis across independent surgeons
through week 2
Interrater Reliability of SKIN Score
Time Frame: through week 2
consistency of SKIN score across independent surgeons
through week 2
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.
through week 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Mastectomy Skin Flap Necrosis
Time Frame: through week 2
number of participants with mastectomy skin flap necrosis
through week 2
Severity of Mastectomy Skin Flap Necrosis
Time Frame: through week 2
severity of mastectomy skin flap necrosis measured by SKIN score
through week 2
Timing of Necrosis Onset
Time Frame: through week 2
number of days until onset of postoperative necrosis
through week 2
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)
through week 2
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)
through week 2
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
through week 2
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
through week 2
Length of Hospital Stay
Time Frame: through week 2
number of days participants spent admitted to the hospital
through week 2
Length of Follow Up
Time Frame: through week 2
number of weeks participants were followed post discharge
through week 2

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Data Completeness Rate
Time Frame: through week 2
Percent of planned outcome data collected
through week 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
through week 2
Use of Indocyanine Green Angiography
Time Frame: through week 2
number of surgeons that used indocyanine green angiography
through week 2
Change from preoperative plan to final operation
Time Frame: through week 2
number of surgeons that changed their preoperative plan before the final operation
through week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adam Katz, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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