Thermal Preconditioning for Breast Reconstruction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a heating device designed to improve recovery after breast reconstruction surgery. Researchers aim to determine if using this device (thermal preconditioning) before surgery can lead to better patient outcomes. Participants will either try different heating routines or join a group that reviews past cases without the treatment. This trial targets individuals planning a mastectomy with immediate breast reconstruction, who have not undergone prior radiation therapy or have inflammatory breast cancer. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance surgical recovery for future patients.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that the breast heat preconditioning device is safe for use in breast reconstruction?
Research has shown that applying heat to the skin, known as thermal preconditioning, can be safe and beneficial for patients. One study found that using heat before surgery reduced skin damage in patients undergoing immediate breast reconstruction, suggesting the treatment is generally well-tolerated. Additionally, a review of several studies has shown that thermal preconditioning often leads to positive outcomes, such as improved survival of organs or tissues, without major safety concerns. While more research is needed to confirm these findings, current evidence is promising for this approach.12345
Why are researchers excited about this trial?
Researchers are excited about thermal preconditioning for breast reconstruction because it offers a novel, non-invasive approach to potentially improve surgical outcomes. Unlike traditional treatments focused on post-operative recovery, this technique involves pre-surgery preparation by applying cycles of heating and cooling to the breast. This method aims to enhance tissue resilience and healing by conditioning the tissue before surgery, which could lead to better results and faster recovery times. By exploring both multiple and single preconditioning cycles, researchers hope to determine the most effective way to prepare tissue, paving the way for advancements in reconstructive surgery protocols.
What evidence suggests that the thermal preconditioning device is effective for breast reconstruction?
Research has shown that heat therapy before breast reconstruction surgery can benefit patients who have undergone a mastectomy. In this trial, participants will experience different thermal preconditioning cycles. One group will alternate between 30 minutes of heating and 30 minutes of spontaneous cooling to the breast 12 hours before the operation, repeated three times. Another group will undergo one cycle of alternating 30 minutes of heating and 30 minutes of cooling in the preoperative area 1 hour before the operation. Applying local heat before surgery can reduce the risk of skin damage, potentially aiding in better skin healing. Most studies have found positive effects, such as improved survival of transplanted tissue or enhanced joint movement, when heat therapy is applied. These findings suggest that heat therapy can enhance recovery after surgery.12345
Who Is on the Research Team?
Adam Katz, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) planning to have a mastectomy with immediate breast reconstruction at Atrium Health Wake Forest Baptist. People can't join if they aren't having reconstruction, have certain skin conditions, are pregnant, have had chest radiation, can't consent, or have inflammatory breast cancer.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
Trial Overview
The study tests whether using a special warming device on the breast before surgery (either once or three times) helps improve recovery after mastectomy and immediate reconstruction compared to not using the device.
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
Citations
A randomised controlled feasibility trial to evaluate local heat ...
Local heat preconditioning of the MSF before surgery has been shown to reduce skin necrosis in immediate breast reconstruction patients (IBR).
Thermal Preconditioning for Breast Reconstruction
The purpose of this research study is to understand patient experiences and the feasibility of using a breast heat preconditioning device ...
Thermal Preconditioning for Surgery: A Systematic Review
Most studies demonstrated a beneficial effect of thermal preconditioning, ranging from increased joint mobility to improved flap or organ transplant survival ...
study protocol and statistical analysis plan for the PREHEAT trial
There is evidence that heat preconditioning could help improve the provision of skin-sparing mastectomy at minimal cost by reducing the ...
5.
ctv.veeva.com
ctv.veeva.com/study/thermal-preconditioning-in-mastectomy-patients-with-immediate-breast-reductionThermal Preconditioning in Mastectomy Patients With ...
The purpose of this research study is to understand patient experiences and the feasibility of using a breast heat preconditioning device ...
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