Joris van Dongen

226 Chapter 10 MATERIAL & METHODS Study overview This study was conducted from July 2016 to November 2019 as a single-center, double-blind (patient as well as investigator), randomized, placebo-controlled clinical trial at Bergman Clinics The Hague, the Netherlands. The study protocol was carried out in compliance with the Declaration of Helsinki and was approved by the national medical ethics committee (CCMO) of The Netherlands (National legislator trial code: NL54409.000.15, Dutch trial register code: NTR5703). All subjects provided written informed consent prior to start of the study. Patient population and randomization A power calculation was performed to calculate the total number of subjects required for this study (n=64). Subjects were randomly divided into two groups: the experimental group received subcutaneous lipofilling with additional transcutaneous PRP and tSVF injections, while the control group received subcutaneous lipofilling with additional transcutaneous PRP as well as sterile saline injections, to serve as placebo. In- and exclusion criteria are listed in table 1. Patient enrollment started in June 2016 and ended prematurely in November 2019 because the required pace of inclusion was not met endanger completion of the study. After enrollment, subjects were prohibited to undergo any facial rejuvenation procedure as well as to start smoking. If subjects still did, subjects were excluded from the study. Harvesting and injection of condensed lipoaspirate Liposuction, processing and deep and superficial lipofilling was performed using Sorenson harvesting (2.4 x 22 cm) and smaller curved lipofilling cannulas (0.9 x 5 cm, Tulip, Medical Products, San Diego, CA). 16-18 In short, 100 ml of adipose tissue was harvested from the upper legs, centrifuged and 15-18 ml was injected immediately after processing against the inside of the skin to each side of the face. The part of the injection side that was used for assessment was outlined by the mandible bone, the nostril, lower eyelid, corner of the eyebrow till the earlobe. In this particular area 6 ml of condensed lipoaspirate was injected as superficial lipofilling keeping the round tip of the curved canula upwards against the inside of the skin. Remaining condensed lipoaspirate was used as deep lipofilling. All patients were treated under sedative anesthesia using Propofol and remifentanil intravenously.