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IRCT20130311012782N43 IRCT 2020-03-16 Esfahan University of Medical Sciences Comparison of shelf life of fresh and frozen injections of facial rejuvenation Comparison of survival in serial autologous fat transfer between freezed and fresh fat in face rejuvenation 2020-04-03 anticipated 60 Complete https://irct.ir/trial/45963 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of patients in two groups is done by Random Allocation Software. The total sample size is then entered into the software and then the number of groups is determined. The output of the software is a list containing numbers from one to 60 that are distributed randomly into two groups. According to the list, Patients are distributed into two groups according to the time of referral in order to reach the required sample size in each group, Blinding description: Because of the frequency of adipose tissue differentiation between the two groups, it is not possible to blind the patient. Liposuction and injection are performed by the researcher, but the outcome of treatment and evaluation of the effects of the injection are performed by other plastic surgeon who That is unaware of the study. 3 Facial wrinkles. Intervention 1: Intervention group 1: In this group,during tree time of visit, about 10 ml of fresh fat is aspirated from the inner thigh and after purification, 3 ml is injected on both sides of the nasolibial folds. The frequency of fat injections will be three times with 3 weeks interval. Intervention 2: Intervention group 2: In this group, about 30 ml of fat is aspirated from the inner part of the thigh and after purification, 3 ml is injected on both sides of the nasolibial folds. The residual fat is freeze at -18 ° C and is injected at similar volume for the two next injections with interval of three weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is The project is owned by the government agency and its information is not available.
public Mahmoud Omranifard
Alzahra hospital, Soffeh street
Isfahan Iran (Islamic Republic of) 8434193474 0098 36685555 omranifard@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mahmoud Omranifard
Alzahra hospital, Soffeh street
Isfahan Iran (Islamic Republic of) 8434193474 0098 36685555 omranifard@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Candidate for fat injection for facial rejuvenation Patient's consent to participate in the study 18 years 69 years Both History of any type of allergy R23.4 changes in skin texture Treatment - Surgery Treatment - Surgery Intervention group 1: In this group,during tree time of visit, about 10 ml of fresh fat is aspirated from the inner thigh and after purification, 3 ml is injected on both sides of the nasolibial folds. The frequency of fat injections will be three times with 3 weeks interval. Intervention group 2: In this group, about 30 ml of fat is aspirated from the inner part of the thigh and after purification, 3 ml is injected on both sides of the nasolibial folds. The residual fat is freeze at -18 ° C and is injected at similar volume for the two next injections with interval of three weeks Facial Wrinkles. Timepoint: Every 3 months. Method of measurement: Modified Fitzpatrick Wrinkle Scale. Survival Fat injected. Timepoint: every 3 months. Method of measurement: Physical Examination. Esfahan University of Medical Sciences Approved 2019-07-01 Ethics committee of Isfahan University of Medical Sciences Alzahra hospital, Soffeh street Isfahan Isfehan Iran (Islamic Republic of)