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NCT07516483
Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction
Conditions: Breast Reconstruction After Mastectomy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Wake Forest University Health Sciences
Location: Wake Forest University Health Sciences Winston-Salem North Carolina
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07516483). StuddyBuddy aggregates publicly available trial information.
