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

Not Applicable

Recruiting

• Conditions: Mammaplasty; Mastectomy; Breast Reconstruction

• 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: 2025-07
• Last Update Submitted: 2025-07-30
• Last Update Posted: 2025-07-31
• Primary Completion: 2027-01
• Study Completion: 2027-01-01

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

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