Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 1 Cycle Thermal Preconditioning, 3 Cycles Thermal Preconditioning, No Intervention.
- Who it may be relevant to
- Registry conditions: Breast Reconstruction After Mastectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Thermal Preconditioning in Patients Undergoing Mastectomy With Planned Immediate Breast Reconstruction: A Randomized Feasibility Trial
Overview
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.
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.
Interventions
- 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. - 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. - Other No Intervention
participants did not receive intervention
Primary outcome measures
- Recruitment Rate [Time frame: through week 2]
- Protocol Adherence Rate [Time frame: through week 2]
- Interrater Reliability of Mastectomy Skin Flap Necrosis [Time frame: through week 2]
- Interrater Reliability of SKIN Score [Time frame: through week 2]
- Participant Feedback Survey Score [Time frame: through week 2]
Secondary outcome measures (9)
- Incidence of Mastectomy Skin Flap Necrosis [Time frame: through week 2]
- Severity of Mastectomy Skin Flap Necrosis [Time frame: through week 2]
- Timing of Necrosis Onset [Time frame: through week 2]
- Number of Intraoperative Deviations [Time frame: through week 2]
- Number of Postoperative Wound Complications [Time frame: through week 2]
- Number of Expander Failures [Time frame: through week 2]
- Number of Returns to the Operating Room [Time frame: through week 2]
- Length of Hospital Stay [Time frame: through week 2]
- Length of Follow Up [Time frame: through week 2]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT07516483 · IRB00146716