Breast Reconstruction After Mastectomy
Conditions
Keywords
heat preconditioning, mastectomy, breast reconstruction
Brief 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.
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
OTHER1 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.
OTHER3 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.
OTHERNo Intervention
participants did not receive intervention
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Feedback Survey Score | through week 2 | Participants will be given an 11-item questionnaire with total score range 11-55 with lower scores indicating higher level of satisfaction. |
| Recruitment Rate | through week 2 | Percent of eligible patients who consent |
| Protocol Adherence Rate | through week 2 | Percent of participants compliant with preconditioning as assigned |
| Interrater Reliability of Mastectomy Skin Flap Necrosis | through week 2 | consistency of flap necrosis diagnosis across independent surgeons |
| Interrater Reliability of SKIN Score | through week 2 | consistency of SKIN score across independent surgeons |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Follow Up | through week 2 | number of weeks participants were followed post discharge |
| Number of Intraoperative Deviations | through week 2 | Number of intraoperative deviation from planned reconstruction (e.g. aborted immediate reconstruction, expander deflation, closure over drains) |
| Severity of Mastectomy Skin Flap Necrosis | through week 2 | severity of mastectomy skin flap necrosis measured by SKIN score |
| Timing of Necrosis Onset | through week 2 | number of days until onset of postoperative necrosis |
| Incidence of Mastectomy Skin Flap Necrosis | through week 2 | number of participants with mastectomy skin flap necrosis |
| Number of Postoperative Wound Complications | through week 2 | Number of participants with postoperative wound complications (e.g., infection, incision dehiscence, flap erosion, expander exposure) |
| Number of Expander Failures | through week 2 | Number of participants with expander failure defined as explantation, loss, or non-use due to flap compromise |
| Number of Returns to the Operating Room | through week 2 | Number of participants that returned to the Operating Room due to necrosis or related complications |
| Length of Hospital Stay | through week 2 | number of days participants spent admitted to the hospital |
Countries
United States
Contacts
CONTACTCaleb Suggs
PRINCIPAL_INVESTIGATORAdam Katz, MD
Wake Forest University Health Sciences
Outcome results
None listed