Abstract

Botulinum toxin A (BTX-A) can enhance the efficacy of fat grafting. However, most studies conducted animal experiments, lacked objective clinical data, or were non-randomized controlled trials. Thus, objective evaluation of the clinical effectiveness of BTX-A is still elusive. A randomized, self-controlled trial (2020-2022) on 16 patients who underwent bilateral autogenous fat breast augmentation was performed with each patient receiving autologous fat graft and BTX-A on one side and fat graft and equal volume of saline on the other side. All patients were followed. The effects of BTX-A were evaluated objectively by comparing the remaining bilateral fat graft volumes obtained through digital three-dimensional reconstruction. The improvement of each breast appearance and complication were assessed by the physician and patients who were blinded to the treatment. The outcome of fat breast augmentation was evident for both sides at follow-up with no evidence of fat embolism, vascular/nervous injury, infection, and prolonged bruising. The analysis of the three-dimensional reconstruction data and assessments from both physicians and patients showed significant differences in the fat graft retention volume between the BTX-A side and the control side. No significant difference was found in the incidence of complications between the two sides. Autogenous fat breast augmentation is safe and effective. This study shows that BTX-A can significantly improve the retention rate of fat transplantation, but cannot reduce complications. Trial registration This study was registered prior to patient enrollment (ClinicalTrials.gov identifier:ChiCTR2100054878). This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

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