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

Not Applicable

Recruiting

• Conditions: Mammaplasty; Mastectomy; Breast Reconstruction
• Interventions: Device: REVOLVE Advanced Adipose System; Procedure: Viality; Device: LipoGrafter

• Registration Number: NCT04891510
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-18
• Study Start: 2021-05-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REVOLVE Advanced Adipose System	REVOLVE Advanced Adipose System	Participants will receive the REVOLVE Advanced Adipose System technique during breast reconstruction.
Viality	Viality	Participants will receive the Viality technique during breast reconstruction.
LipoGrafter	LipoGrafter	Participants will receive the LipoGrafter technique during breast reconstruction.

Primary Outcome Measures

Name	Time	Method
Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site	Baseline, 90 day follow-up	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.
Change in patient satisfaction of fat grafting technique, as measured by the BREAST-Q questionnaire	Baseline, 90 day follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Number of palpable masses from the fat grafting technique, as measured by a physical exam.	90 day follow-up	The physical exam will provide the number of palpable masses at the surgical site.
Presence seroma from the fat grafting technique, as measured by a physical exam	90 day follow-up	The physical exam will show if there is seroma present at the surgical site. This is a binary "yes/no" item.
Number of lesions of probable fat necrosis from the fat grafting technique, as measured by a physical exam	90 day follow-up	The physical exam will provide the number of lesions of probable fat necrosis at the surgical site
Presence of infection from the fat grafting technique, as measured by a physical exam	90 day follow-up	The physical exam will show if there is infection present at the surgical site. This is a binary "yes/no" item.
Assessment of wound healing from the fat grafting technique, as measured by a physical exam	90 day follow-up	The physical exam will show if wound healing is normal or delayed at the surgical site. This is a binary "normal/delayed" item.

Trial Locations

Locations (1)

New York Presbyterian - Weill Cornell Medicine; 🇺🇸 New York, New York, United States