Response to Letter to Editor regarding the RESTORE-2 trial: Proof of safety and efficacy of 'regenerative-cell enriched' fat-grafting?

摘要

We appreciate this letter's comments regarding Perez-Cano et al. and the emphasis on the study's limitations. Throughout the article, the multi-institutional group of authors have carefully tried to communicate both the study limitations as well as present a balanced picture of its findings.However, the authors of the letter mischaracterize the purpose of the study, which was in fact to prospectively and longitudinally determine if a new breast reconstructive technique in a narrow indication is safe and effective. This is the largest study in defects after breast conservation to date. The very indication in which traditional fat grafting is struggling with poor graft take.1 The stated purpose was not to compare one technique of fat grafting against another, although we agree that comparative trials are ultimately very important. But, prior to any comparative trials, the safety and efficacy of the new or emerging treatment method needs to be ascertained and its potential utility determined to power the statistical analysis of future studies.