Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this 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.
Eligibility criteria
Qualifiers
Adult patients (≥ 18 years of age) undergoing prophylactic or therapeutic mastectomy with planned immediate breast reconstruction at Atrium Health Wake Forest Baptist Medical Center.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 1 Cycle Thermal Preconditioning
- 3 Cycles Thermal Preconditioning
- No Intervention
Treatment groups
40 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov