Thermal Preconditioning for Breast Reconstruction
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Adam Katz, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preconditioning
Participants undergo thermal preconditioning with either 3 cycles or 1 cycle of heating and cooling prior to mastectomy and reconstruction
Treatment
Participants undergo mastectomy with immediate breast reconstruction
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Thermal Preconditioning
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
three cycles of alternating between 30 minutes heating and 30 minutes spontaneous cooling to the breast 12 hours before operation.
one cycle of alternating between 30 minutes heating and 30 minutes cooling in the preoperative area 1 hour before operation.
retrospective chart review of patients meeting the same eligibility criteria who did not receive prospective interventions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.