Joris van Dongen

265 Facial lipografting on skin quality: a systematic review to establish significant differences between the experimental and the placebo group. 107 Also, to treat a patient with placebo and subject the patient to all the potential risk of surgery is generally seen as ethically undesirable. However, treating a patient with a non-scientifically proven treatment is ethically undesirable as well. Hence, most clinical trials compare two different treatments, which makes it challenging to establish any significant difference in outcome and real effect of the treatment. To date, the readouts to quantify skin rejuvenation are mainly based on pre- and postoperative photographic comparisons, which often are not or poorly standardized. These pre- and postoperative photographs are often analysed in a descriptive manner instead of being blinded analysed by an objective and independent third observer or are the result from objective, validated, computer analysis. To improve future clinical trials using facial lipofilling in aesthetic plastic surgery, we propose a statement for designing a proper randomized clinical trial with validated and objective readouts (Table 7). In this way, comparing outcomes of future clinical trials can draw a definite conclusion on the effect of facial lipofilling on skin quality. The study population should consist of a standardized group with ASA1 classification and a minimum age of 35, because skin elasticity is higher in younger patients. 108 Patients with obesity, systemic diseases, smokers and hormonal fluctuations should be excluded because all of these factors influence adipose tissue quality as well as skin quality. 38,109-111 Moreover, patients with preceding facial interventions within the last twelve months should be excluded because of late effects of priory interventions. Patients with a known history of psychiatric disorder should also be excluded because this could influence patient satisfaction outcomes. To date, there is no consensus on the quality of lipoaspirate harvested from different locations e.g. abdomen, upper legs as well as injection volumes and lipoaspirate processing techniques e.g. centrifugation, decantation. 33,35,37 Thus, we propose a standard harvesting location in all trial patients and to centrifuge lipoaspirate as first described by Coleman to ensure the right amount of lipoaspirate by losing infiltration fluid. 112 Injection volumes should be standardized during the entire study and there should be a maximum time of 30 min. between harvesting and injection to prevent ischemic cell death. Finally, we propose the use of the validated cutometer as primary outcome since loss of skin elasticity is strongly correlated with ageing. 113 Secondary outcomes should include: patient reported outcome measures i.e . satisfaction as measured with the validated FACE-Q questionnaires, clinical photographs analyses (by blinded and independent observers) and complications (number and type). Nowadays, the indication for lipografting has already proven its efficacy for other clinical applications e.g. as a treatment to increase volume for cosmetic and/or