A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery

Breast Reconstruction Clinical Trial

Official title:

A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04891510
• Other study ID #: 20-10022850
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Weill Medical College of Cornell University
• Contact: Makayla Kochheiser
• Phone: 740.816.9707
• Email: mlk4002[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Reconstruction
• Mammaplasty
• Mastectomy

Intervention

Device:
• REVOLVE Advanced Adipose System
The REVOLVE system is an all-in-one fat processing device that harvests, filters, actively washes, and removes strands from lipoaspirate and allows for reinjection without any additional manipulation (REVOLVE 2020).
• LipoGrafter
The LipoGrafter system is designed to be a start-to-finish closed system with minimal processing of the lipoaspirate, minimizing the risk of contamination and fat cell damage (LipoGrafter 2020).

Procedure:
• Viality
The Viality system uses the AuraClens solution that acts as a surfactant to bring impurities like blood, free oil, and cellular debris into solution, where they can be flushed out through suction.

Locations

Country	Name	City	State
United States	New York Presbyterian - Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site	3D volumetric scanning assesses the fat graft retention defined as the ratio of fat remaining at the surgical site at 90 day follow-up to that at pre-operative baseline.	Baseline, 90 day follow-up
Primary	Change in patient satisfaction of fat grafting technique, as measured by the BREAST-Q questionnaire	The BREAST-Q questionnaire is used for measuring pre- and postoperative psychosocial, physical, and sexual well-being, satisfaction with breasts, experience of care, and satisfaction with outcome. Scores range on a 0-100 scale, with higher scores indicating better outcomes.	Baseline, 90 day follow-up
Secondary	Number of palpable masses from the fat grafting technique, as measured by a physical exam.	The physical exam will provide the number of palpable masses at the surgical site.	90 day follow-up
Secondary	Number of lesions of probable fat necrosis from the fat grafting technique, as measured by a physical exam	The physical exam will provide the number of lesions of probable fat necrosis at the surgical site	90 day follow-up
Secondary	Presence of infection from the fat grafting technique, as measured by a physical exam	The physical exam will show if there is infection present at the surgical site. This is a binary "yes/no" item.	90 day follow-up
Secondary	Presence seroma from the fat grafting technique, as measured by a physical exam	The physical exam will show if there is seroma present at the surgical site. This is a binary "yes/no" item.	90 day follow-up
Secondary	Assessment of wound healing from the fat grafting technique, as measured by a physical exam	The physical exam will show if wound healing is normal or delayed at the surgical site. This is a binary "normal/delayed" item.	90 day follow-up