Is there an ideal recipient site preconditioning to improve autologous fat graft retention in breast surgery? A prospective multi-center randomized controlled trial.
Speck NE., Ciftci Ü., Speck NM., Oranges CM., Popp A., Allen R.
Randomized Controlled Trial on Scar, published in J Plast Reconstr Aesthet Surg (2025) — summary generated from the PubMed abstract.
Several human studies show positive signals, while research methods and sample sizes continue to develop.
- Level A · Stronger Clinical Evidence
- Level B · Emerging clinical evidence with positive signals
- Level C · Early human research exploring benefits
- Level D · Scientific groundwork from lab and animal studies
- Emerging · Emerging topic under active research
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- Study type
- Randomized Controlled Trial
- Journal
- J Plast Reconstr Aesthet Surg (2025)
- Country
- Netherlands
- Reported sample size
- —
- Source database
- PubMed
- PMID
- 41389580
- DOI
- 10.1016/j.bjps.2025.11.044
- NCT
- NCT03393598
Abstract (original English)
Background Autologous fat grafting (AFG) is a popular method for soft tissue augmentation and reconstruction due to its regenerative potential and minimally invasive nature. However, variability in fat graft retention remains a major limitation. While research has focused on optimizing fat harvesting and processing techniques, the role of recipient site preparation has been understudied. This trial evaluated whether preconditioning the recipient site-via pre-expansion, pre-heating, or both-could enhance fat graft retention around the breast six months post-operatively. Patients and methods In a prospective, multi-center, randomized controlled trial (RCT) with a 2×2 factorial design, 60 female patients were assigned to one of four groups: (1) pre-expansion using the Kiwi® VAC-6000M with PalmPump™, (2) pre-heating using the HILOTHERM® Calido system, (3) a combination of both interventions, or (4) a control group without preconditioning. The primary outcome was the percentage of fat graft volume retained at the breast at six months relative to baseline at screening. Secondary outcomes included scar quality (Patient and Observer Scar Assessment Scale), pain levels (Numeric Rating Scale), and complications (Clavien-Dindo classification). Results No statistically significant difference in fat retention was observed between the treatment and control groups at six months. All groups (i
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
Evidence level
Several human studies show positive signals, while research methods and sample sizes continue to develop.
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