Comparing fat processing methods for breast reconstruction after mastectomy
A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
NA · Weill Medical College of Cornell University · NCT04891510
This study is testing which fat processing method works best for keeping fat grafts in place during breast reconstruction after mastectomy for women who have enough fat to use.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Weill Medical College of Cornell University (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04891510 on ClinicalTrials.gov |
What this trial studies
This study aims to determine which fat processing method—REVOLVE, LipoGrafter, or Viality—provides the best graft retention in patients undergoing breast reconstruction following mastectomy. It involves female participants with a history of breast surgery who have sufficient fat available for grafting. The study will assess the effectiveness of these methods in enhancing the outcomes of breast reconstruction procedures.
Who should consider this trial
Good fit: Ideal candidates are females with a documented history of previous breast surgery and sufficient fat for grafting.
Not a fit: Patients who are pregnant or have a BMI below 20 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the success rates of fat grafting in breast reconstruction, leading to better aesthetic outcomes for patients.
How similar studies have performed: Other studies have explored various fat processing methods, but this specific comparative analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female; * Documented history of previous breast surgery (either complete or partial mastectomy); * Available harvest sites for fat grafting as documented by plastic surgeon; * BMI \> 20; * Anticipated harvested fat volume \> 50cc; * Competency and willingness to provide consent Exclusion Criteria: * Suspected or known to be pregnant
Where this trial is running
New York, New York
- New York Presbyterian - Weill Cornell Medicine — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: David Otterburn, MD — Weill Medical College of Cornell University
- Study coordinator: Makayla Kochheiser
- Email: mlk4002@med.cornell.edu
- Phone: 740.816.9707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mastectomy, Mammaplasty, Breast Reconstruction