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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 Preconditioning Cycles | Experimental | three cycles of alternating between 30 minutes heating and 30 minutes spontaneous cooling to the breast 12 hours before operation. |
|
| 1 Preconditioning Cycle | Experimental | one cycle of alternating between 30 minutes heating and 30 minutes cooling in the preoperative area 1 hour before operation. |
|
| Retrospective Group | Active Comparator | retrospective chart review of patients meeting the same eligibility criteria who did not receive prospective interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 Cycle Thermal Preconditioning | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Percent of eligible patients who consent | through week 2 |
| Protocol Adherence Rate | Percent of participants compliant with preconditioning as assigned | through week 2 |
| Interrater Reliability of Mastectomy Skin Flap Necrosis | consistency of flap necrosis diagnosis across independent surgeons | through week 2 |
| Interrater Reliability of SKIN Score | consistency of SKIN score across independent surgeons | through week 2 |
| Participant Feedback Survey Score | Participants will be given an 11-item questionnaire with total score range 11-55 with lower scores indicating higher level of satisfaction. | through week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Mastectomy Skin Flap Necrosis | number of participants with mastectomy skin flap necrosis | through week 2 |
| Severity of Mastectomy Skin Flap Necrosis | severity of mastectomy skin flap necrosis measured by SKIN score |
| Measure | Description | Time Frame |
|---|---|---|
| Data Completeness Rate | Percent of planned outcome data collected | through week 2 |
| Blinding Success Rate | number of surgeons that remained unaware of allocation during image-based diagnosis and grading of necrosis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caleb Suggs | Contact | 3367134339 | caleb.suggs@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Adam Katz, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| 3 Cycles Thermal Preconditioning | Other | 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. |
|
| No Intervention | Other | participants did not receive intervention |
|
| through week 2 |
| Timing of Necrosis Onset | number of days until onset of postoperative necrosis | through week 2 |
| Number of Intraoperative Deviations | Number of intraoperative deviation from planned reconstruction (e.g. aborted immediate reconstruction, expander deflation, closure over drains) | through week 2 |
| Number of Postoperative Wound Complications | Number of participants with postoperative wound complications (e.g., infection, incision dehiscence, flap erosion, expander exposure) | through week 2 |
| Number of Expander Failures | Number of participants with expander failure defined as explantation, loss, or non-use due to flap compromise | through week 2 |
| Number of Returns to the Operating Room | Number of participants that returned to the Operating Room due to necrosis or related complications | through week 2 |
| Length of Hospital Stay | number of days participants spent admitted to the hospital | through week 2 |
| Length of Follow Up | number of weeks participants were followed post discharge | through week 2 |
| through week 2 |
| Use of Indocyanine Green Angiography | number of surgeons that used indocyanine green angiography | through week 2 |
| Change from preoperative plan to final operation | number of surgeons that changed their preoperative plan before the final operation | through week 2 |