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Thermal Preconditioning for Breast Reconstruction After Mastectomy

This study is looking at whether using a special device called Plexaa BLOOM43 to warm the breast before surgery can help improve recovery for patients having a mastectomy (surgery to remove a breast) and immediate breast reconstruction. You could be eligible if you are an adult (18 or older) having a mastectomy with planned immediate breast reconstruction at Atrium Health Wake Forest Baptist Medical Center. Patients with inflammatory breast cancer or a history of radiation to the breast/chest wall cannot join. The study aims to see how many people join, how well they follow the study plan, and how consistently doctors can identify skin flap issues after surgery. The study status is unclear, and it plans to enroll 40 participants.

Study design
This is a prospective, single-center, two-arm randomized study comparing two preconditioning interventions, with a separate retrospective control group. About 40 participants will be enrolled.
What's involved
Participants will use the Plexaa BLOOM43 device on their breast for either 1 hour (one cycle) or 3 hours (three cycles) before surgery. The study will measure outcomes for up to two weeks after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to two weeks after surgery to assess recruitment rate, protocol adherence, and interrater reliability of mastectomy skin flap necrosis.

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NCT07516483

Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Wake Forest University Health Sciences
~40 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:1 Cycle Thermal Preconditioning3 Cycles Thermal PreconditioningNo Intervention

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment Rate
Measured over through week 2
+4 more outcomes measured

Conditions

Breast Reconstruction After Mastectomy

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Adam Katz, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Caleb Suggs
[email protected]
3367134339
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Recruitment Ratethrough week 2

    Percent of eligible patients who consent

  • Protocol Adherence Ratethrough week 2

    Percent of participants compliant with preconditioning as assigned

  • Interrater Reliability of Mastectomy Skin Flap Necrosisthrough week 2

    consistency of flap necrosis diagnosis across independent surgeons

  • Interrater Reliability of SKIN Scorethrough week 2

    consistency of SKIN score across independent surgeons

  • Participant Feedback Survey Scorethrough week 2

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