Not Yet RecruitingNot Applicable

Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction

United States40 participantsStarted 2026-05

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Recruitment Rate

Timeframe: through week 2

Protocol Adherence Rate

Timeframe: through week 2

Interrater Reliability of Mastectomy Skin Flap Necrosis

Timeframe: through week 2

Interrater Reliability of SKIN Score

Timeframe: through week 2

Participant Feedback Survey Score

Timeframe: through week 2

Trial details

NCT IDNCT07516483

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Caleb Suggs

3367134339 caleb.suggs@advocatehealth.org

View on ClinicalTrials.gov More Breast Reconstruction After Mastectomy trials