Fat Grafting for Breast Reconstruction

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Unwilling to participate

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is studying how fat grafting affects blood flow in the breast skin of patients who have had a mastectomy and radiation therapy. The goal is to see if adding fat can improve skin health. Fat grafting has been increasingly recognized as a tool to rejuvenate irradiated skin and improve skin quality in patients who have undergone radiation therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

How is fat grafting different from other breast reconstruction treatments?

Fat grafting for breast reconstruction is unique because it uses the patient's own fat, harvested from other parts of the body, to rebuild the breast. This method can be used alone or in combination with other techniques, and it avoids the use of implants, making it a more natural option for some patients. It is particularly suitable for those who are not candidates for major surgery or who prefer to avoid long scars. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Fat Grafting for Breast Reconstruction?

Research shows that fat grafting can effectively improve breast appearance after reconstruction, correct deformities, and enhance skin thickness, especially when combined with techniques like pre-expansion with BRAVA. It is also noted for creating a natural look and improving tissue quality in radiated areas. ^{4 5 6 7 8}

Who Is on the Research Team?

Christin A. Harless, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for breast cancer patients who have had a mastectomy and are undergoing immediate reconstruction with tissue expanders or implants that require radiation therapy. It's not open to those who do not wish to participate.

Inclusion Criteria

I am a breast cancer patient getting an implant or tissue expander with planned radiation therapy.

I have had a mastectomy.

Exclusion Criteria

I am willing to participate in the clinical trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo radiation therapy as part of their post-mastectomy treatment

6-8 weeks

Fat Grafting

Participants receive autologous fat transfer to the breast(s) to improve skin perfusion

1-2 weeks

Follow-up

Participants are monitored for radiation fibrosis and skin perfusion changes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Fat Grafting

Trial Overview The study is looking at how well blood flows through the skin of the breast after it has been treated with radiation and then fat grafting. This will help understand if fat grafting improves skin condition post-radiation.

How Is the Trial Designed?

Group I: Breast reconstruction with fat grafting Experimental Treatment 1 Intervention

fat grafting

Group II: breast reconstruction without fat grafting Active Control 1 Intervention

No Fat grafting

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The Need for Core Outcome Reporting in Autologous Fat Grafting for Breast Reconstruction. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Total envelope fat grafting: a novel approach in breast reconstruction. [2021]

3. France pubmed.ncbi.nlm.nih.gov

[Tolerance of pre-expansion BRAVA and fat grafting into the breast]. [2022]

4. Denmark pubmed.ncbi.nlm.nih.gov

[Fat grafting of the breast]. [2019]

5. France pubmed.ncbi.nlm.nih.gov

[Autologous fat grafting in radiated tissue prior to breast prosthetic reconstruction: is the technique reliable?]. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Fat Grafting to the Breast: Clinical Applications and Outcomes for Reconstructive Surgery. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Fat Grafting to the Breast for Aesthetic Indications: Techniques and Outcomes in 165 Consecutive Patients. [2023]

8. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Full breast reconstruction with fat and how to recycle the "dog-ear". [2020]