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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Autologous Fat Grafting Techniques for Breast Surgery?

Research indicates that autologous fat grafting, including the use of the REVOLVE System, is a reliable and safe method for breast reconstruction and augmentation, offering an alternative to implants and flap surgery. The REVOLVE System improves the efficiency and consistency of fat processing, which can enhance the success of the procedure. ^{1 2 3 4 5}

Is autologous fat grafting for breast surgery generally safe?

Autologous fat grafting, including techniques like the REVOLVE System and others, is generally considered safe with minor risks. Studies have shown that complications are low, and there is no proven risk of tumor induction from this procedure. ^{1 3 6 7 8}

What makes the treatment 'Autologous Fat Grafting Techniques for Breast Surgery' unique?

This treatment is unique because it uses a patient's own fat, processed through advanced systems like LipoGrafter and REVOLVE, to enhance breast shape and volume, offering a natural alternative to implants. The technique involves specific methods like washing, filtering, and centrifugation to prepare the fat, which may improve the safety and effectiveness of the procedure compared to traditional methods. ^{4 5 6 9 10}

Research Team

David Otterburn, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Autologous Fat Grafting to the Breast Using REVOLVE System to Reduce Clinical Costs. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[The influence of harvesting and processing on the regenerative potential in fat grafting]. [2021]

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

Autologous Fat Grafting in Plastic and Reconstructive Surgery: An Historical Perspective. [2023]

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

Autologous fat grafting: in search of the optimal technique. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A Novel Approach for Tuberous Breast Correction Using Power-Assisted Liposuction, Loops, and Lipofilling (PALLL). [2022]

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

The Safety of Fat Grafting: An Institutional Retrospective Review. [2023]

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

Safety Profiles of Fat Processing Techniques in Autologous Fat Transfer for Breast Reconstruction. [2021]

8. Germany 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]. [2022]

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

A clinical trial in facial fat grafting: filtered and washed versus centrifuged fat. [2022]

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

Zones for Fat Grafting in Hybrid Breast Augmentation: Standardization for Planning of Fat Grafting Based on Breast Cleavage Units. [2022]