Autologous Fat Grafting Techniques for Breast Surgery

Overseen By Makayla Kochheiser

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Pregnancy

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

135 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best method for using a person’s own fat in breast reconstruction after a mastectomy (surgery to remove breast tissue). It compares different fat-processing techniques, such as the LipoGrafter (also known as Autologous Fat Grafting or Fat Transfer), to determine which method helps the fat remain in place better after surgery. Women who have undergone breast surgery and have sufficient fat for grafting might be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance breast reconstruction techniques.

Will I have to stop taking my current medications?

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

What prior data suggests that these fat grafting techniques are safe for breast reconstruction?

Research has shown that using a patient's own fat for breast reconstruction after a mastectomy is safe. Studies have found no increased risk of cancer recurrence or initiation, indicating that this method does not seem to cause cancer to return or develop.

The BREAST trial found the LipoGrafter technique to be a minimally invasive and safe option. It also improves quality of life, with no safety concerns identified 12 months after the procedure.

The REVOLVE Advanced Adipose System has also been studied and is considered safe, with fewer complications than some other methods. Possible side effects include fat cell death, cysts, infection, or allergic reactions, but these are uncommon.

Overall, both the LipoGrafter and REVOLVE systems are well-tolerated and have good safety records for individuals using their own fat for breast reconstruction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's diving into different techniques for autologous fat grafting in breast surgery, which is a fancy way of saying using your own fat to help in breast reconstruction. Unlike traditional methods that rely heavily on implants, these techniques—Viality, REVOLVE Advanced Adipose System, and LipoGrafter—focus on refining how fat is processed and injected. The REVOLVE system, for instance, aims to purify and concentrate fat more efficiently, potentially leading to better and more consistent results. LipoGrafter provides a streamlined way to harvest and transfer fat with minimal handling, which might improve cell survival. These innovations could offer more natural-looking results and fewer complications, making them exciting options in the world of breast reconstruction.

What evidence suggests that this trial's techniques could be effective for breast reconstruction?

Research shows that using a patient's own fat for breast reconstruction is effective. In this trial, participants will receive one of several techniques. Studies have shown that the LipoGrafter technique retains 69% of the transferred fat in the breast one year after the procedure, indicating that a good portion of the fat remains over time. The REVOLVE Advanced Adipose System efficiently processes and transfers fat, resulting in high-quality breast reconstruction. Both methods are safe and enhance the quality of life for patients using their own tissue for reconstruction. Overall, these techniques show promising results for those undergoing breast reconstruction after a mastectomy. ^{2 3 6 7 8}

Who Is on the Research Team?

David Otterburn, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for women who have had breast surgery, like a mastectomy, and need reconstruction. They should be able to provide consent, have enough fat in certain areas for grafting (over 50cc), and a BMI over 20. Pregnant individuals cannot participate.

Inclusion Criteria

I expect to have more than 50cc of fat removed.

A plastic surgeon has confirmed I have suitable sites for fat grafting.

I am female.

Exclusion Criteria

Suspected or known to be pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo breast reconstruction using one of the three fat grafting techniques: Viality, REVOLVE, or LipoGrafter

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness of the fat grafting technique, including assessments of seroma, wound healing, and fat retention

90 days

Multiple visits (in-person) for physical exams and assessments

What Are the Treatments Tested in This Trial?

Interventions

• LipoGrafter
• REVOLVE Advanced Adipose System
• Standard Decantation technique

Trial Overview The study is comparing three methods of processing fat during breast reconstruction: LipoGrafter, REVOLVE Advanced Adipose System, and the Standard Decantation technique to see which one keeps the most fat after grafting.

How Is the Trial Designed?

Group I: Viality Active Control 1 Intervention

Participants will receive the Viality technique during breast reconstruction.

Group II: REVOLVE Advanced Adipose System Active Control 1 Intervention

Participants will receive the REVOLVE Advanced Adipose System technique during breast reconstruction.

Group III: LipoGrafter Active Control 1 Intervention

Participants will receive the LipoGrafter technique during breast reconstruction.

LipoGrafter is already approved in European Union, United States for the following indications:

Approved in European Union as LipoGrafter for:

• Breast reconstruction after mastectomy

Approved in United States as LipoGrafter for:

• Breast reconstruction after mastectomy
• Cosmetic breast augmentation

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

In a study involving 25 healthy patients, both simple filtered and washed fat and centrifuged fat showed comparable long-term results in facial fat transplantation, indicating that the method of fat processing may not significantly impact clinical outcomes.

After evaluating results through patient questionnaires and expert assessments over an average follow-up of 12 months, the authors decided to revert to using simple filtered fat, suggesting it is a viable and effective option for facial volume restoration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical trial in facial fat grafting: filtered and washed versus centrifuged fat. Botti, G., Pascali, M., Botti, C., et al.[2022]

Autologous fat grafting (AFG) is a widely used technique in plastic and reconstructive surgery that involves transferring a patient's own fat tissue to enhance or reconstruct different body areas.

The methods and applications of AFG have evolved significantly over time, reflecting advancements in surgical techniques and understanding of fat tissue behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous Fat Grafting in Plastic and Reconstructive Surgery: An Historical Perspective. Costanzo, D., Romeo, A., Marena, F.[2023]

Autologous fat grafting is gaining popularity in reconstructive and aesthetic surgery due to advances in understanding adipose cellular biology, which enhances its effectiveness.

The review highlights the importance of refining harvesting and processing techniques to improve fat graft survival and predictability of outcomes, ultimately aiming to enhance safety and reliability in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous fat grafting: in search of the optimal technique. Kakagia, D., Pallua, N.[2022]

A standardized method for autologous fat grafting in breast augmentation was tested on 76 breasts (38 patients), using anatomical zones to improve the procedure's predictability and outcomes.

The study reported a low complication rate of 5.2% over an average follow-up of 12.8 months, indicating that this technique is both safe and effective for enhancing breast shape and coverage of silicone implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zones for Fat Grafting in Hybrid Breast Augmentation: Standardization for Planning of Fat Grafting Based on Breast Cleavage Units. Munhoz, AM., Maximiliano, J., Neto, AAM., et al.[2022]

Autologous fat transplantation is gaining renewed attention and is regulated in Germany, where specific techniques for harvesting and reinjection are recommended to ensure safety and efficacy.

Current evidence suggests that the risks associated with autologous fat transplantation are minor, and there is no proven link to tumor induction, while new techniques like stem cell-enriched fat grafts may enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current perspective and limitations of autologous fat transplantation--"consensus meeting" of the German Society of Plastic, Reconstructive and Aesthetic Surgeons at Hannover; September 2009]. Rennekampff, HO., Reimers, K., Gabka, CJ., et al.[2022]

The PALLL technique for tuberous breast reconstruction, involving matrix modeling and autologous fat transfer, was successfully performed on 47 patients, with a high satisfaction rate of 93% and only one reported infection, indicating its safety and efficacy.

This method allows for significant breast reshaping and volume increase without the use of implants, providing a natural aesthetic outcome that is long-lasting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Approach for Tuberous Breast Correction Using Power-Assisted Liposuction, Loops, and Lipofilling (PALLL). Abboud, MH., Abboud, NM., El Hajj, H.[2022]

Autologous lipotransfer is a safe and reliable method for breast reconstruction and augmentation, providing an alternative to implants and flap surgery.

The success of fat grafting heavily depends on the survival rate of adipose-derived stromal cells (ADSCs), and even minor adjustments in the grafting process can significantly impact their survival, highlighting the need for optimization in techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The influence of harvesting and processing on the regenerative potential in fat grafting]. Klietz, ML., Kückelhaus, M., Wiebringhaus, P., et al.[2021]

The REVOLVE System significantly increases the efficiency of fat transfer procedures, achieving an average rate of 4.69 mL/minute compared to 1.77 mL/minute with the traditional Coleman technique, indicating a faster and potentially more effective method for fat grafting.

Economic analysis shows that for fat transfers of 75 mL or more, the REVOLVE System is more cost-effective than the Coleman technique, suggesting it could be a preferred option for high-volume fat grafting cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous Fat Grafting to the Breast Using REVOLVE System to Reduce Clinical Costs. Brzezienski, MA., Jarrell, JA.[2022]

A review of 396 patients undergoing autologous fat grafting from January 2015 to July 2018 showed that this technique is effective for volumization of the breasts and face, with an average of 124.4 grams of fat grafted per procedure.

While 27.8% of patients experienced complications, most were minor, and no life-threatening issues were reported, indicating that fat grafting is generally safe despite some risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Fat Grafting: An Institutional Retrospective Review. Fang, HA., Soto, E., Pigg, R., et al.[2023]

In a study of 267 patients undergoing autologous fat transfer for breast reconstruction, the centrifugation technique was linked to the highest rates of complications, including oil cysts (12.5%) and total complications (25.6%).

The Telfa gauze method showed the lowest complication rates (0% oil cysts, 2.3% total complications), while the Revolve technique had a significantly lower rate of repeated injections (5.45%) compared to centrifugation (19.6%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profiles of Fat Processing Techniques in Autologous Fat Transfer for Breast Reconstruction. Ruan, QZ., Rinkinen, JR., Doval, AF., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11564784/

Autologous fat grafting for postoperative breast reconstruction One year after transplantation, the maintenance rate of breast volume was 69 % in the PRP group compared to only 39 % in the control group, and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04891510

A Comparative Analysis of REVOLVE, LipoGrafter ... The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.

3. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2802106

Effect of Total Breast Reconstruction With Autologous Fat ... The findings of this study indicate that AFT offers patients with breast cancer an effective and safe option breast reconstruction that uses their own tissue ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1748681525003584

Preliminary data on the oncological safety of autologous fat ... Findings from the BREAST trial demonstrated that AFT is a minimally invasive, effective, and safe option, with superior quality of life outcomes compared to ...

5. journals.lww.com journals.lww.com/plasreconsurg/fulltext/2023/09000/total_breast_reconstruction_with_lipofilling_after.2.aspx

Total Breast Reconstruction with Lipofilling after Traditional After a median follow-up of 2.1 years (range, 0.4 to 6.8 years), the median proportion of transferred fat retained was 58% (range, 14% to 119%), representing a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7882329/

Autologous fat grafting in breast reconstruction There is no clinical evidence that AFG in breast reconstruction is associated with an increased risk of cancer development or recurrence.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6055707/

Meta‐analysis of the oncological safety of autologous fat ... This confirms the results of individual studies that AFT can be performed safely in breast reconstruction after breast cancer surgery. Supporting information.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2352320424001858

Autologous fat grafting for postoperative breast reconstruction Gombos, et al. Brava and autologous fat transfer is a safe and effective breast augmentation alternative: results of a 6-year, 81-patient, prospective ...