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IRCT20210519051343N1 IRCT 2021-11-24 Tehran University of Medical Sciences Evaluation of durability of fat injection with Hyaluronic acid gel (Profhilo) A comparative study of the durability of fat injection alone with respect to fat injection along with the injection of Hyaluronic Acid gel(Profhilo) in the cheeks of patients referred to Razi Hospital in the years 1399-1400 2021-11-21 anticipated 10 Complete https://irct.ir/trial/56838 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Excel software will be used for randomization. In one column, 5 letters A and 5 letters B are recorded, and in the adjacent column, 10 random numbers are created with the Rand () command. The sequence of both columns is then sorted from large to small based on a column of random numbers. The sequence obtained for the letters A and B will be the criteria for entering the two groups of intervention and control, Blinding description: After doing the procedures and taking photographs, the other two dermatologists will separately look at the photographs taken at each visit and will give a score based on the photographs. 2-3 autologous fat transplant with and without Profhilo hyaluronic acid gel. Intervention 1: Intervention group: The group that undergoes hyaluronic acid gel injection after fat injection - selected fat donor sites of the outer thigh. Aspiration is done with a cannula to collect the fat pieces. Then the obtained liquid is centrifuged and then the fat is separated as a yellow and smooth layer and this layer of fat is injected with a 2 ml syringe and canola number 14 can be used. About 30 ml of total fat is injected into the cheeks on both sides. After injection, antibiotics and anti-inflammatory drugs are prescribed. Hyaluronic Acid gel (profhilo) with a dose of 2 ml per session (1 ml on each side of the cheek)is then injected during 2 sessions at intervals 2 and 4 weeks after fat injection. The profhilo injection is done according to the 5 point technique. Intervention 2: Control group: In this group, patients are injected only with fat, which is extracted from the outer part of the thigh and centrifuged, and about 30 ml is injected in each cheek on each side of the patient's face. Patients in this group are not injected with profhilo gel. Yes - There is a plan to make this available What will be shared: All data will be accessible for academic researchers after covering the identities When: after being published by the journal, all data will be accessible forever To whom: for all academic researchers in the field of medicine and pharmacology Conditions: Just for using in research fields and respecting the original researchers in any referencing Where to obtain: emailing the main researcher via this email: marwaakhdar@live.com How to obtain: just an email containing information about the academic position of the researchers and their responsibilities Comments:
public Amir Houshang Ehsani
Razi hospital- razi alley-vahdat esmali square
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0223 ehsanih@sina.tums.ac.ir Tehran University of Medical Sciences scientific Amir Houshang Ehsani
Razi hospital-razi alley- vahdat eslami square
tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0223 ehsanih@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) age between 18 and 70 years old score of Wrinkle Severity Rating Scale between 2-4 patients who don't want to do surgical procedures signing an inform consent 18 years 70 years Both Candidate for cosmetic facial surgery pregnancy and lactation neuromuscular disease uncontrolled systemic disease infection, scar, or abnormality at the site of injection a history of filler or fat injection in the past 12 months patients under treatment with immunosuppressive drugs, aspirin, narcotics, antidepressants, and corticosteroids history of adverse reactions to hyaluronic acid gel and other gels history of adverse reaction to tumescent solution adverse reactions to injection instruments( needle and cannula) facial asymmetry Z41.1 Encounter for cosmetic surgery Treatment - Other Treatment - Other Intervention group: The group that undergoes hyaluronic acid gel injection after fat injection - selected fat donor sites of the outer thigh. Aspiration is done with a cannula to collect the fat pieces. Then the obtained liquid is centrifuged and then the fat is separated as a yellow and smooth layer and this layer of fat is injected with a 2 ml syringe and canola number 14 can be used. About 30 ml of total fat is injected into the cheeks on both sides. After injection, antibiotics and anti-inflammatory drugs are prescribed. Hyaluronic Acid gel (profhilo) with a dose of 2 ml per session (1 ml on each side of the cheek)is then injected during 2 sessions at intervals 2 and 4 weeks after fat injection. The profhilo injection is done according to the 5 point technique. Control group: In this group, patients are injected only with fat, which is extracted from the outer part of the thigh and centrifuged, and about 30 ml is injected in each cheek on each side of the patient's face. Patients in this group are not injected with profhilo gel. Specialist's score based on GAIS-doctor score. Timepoint: baseline-1 month after -6 months after. Method of measurement: Measurement based on the score given by the non-executive physician based on GAIS-doctor score which includes 7 scores:1- very much improved.2-: much improved.3-: improved.4-: no change.5-worse.6- much worse.7- very much worse. Wrinkle severity. Timepoint: baseline-1 month after- 6 months after. Method of measurement: measurement is done according to the Wrinkle Severity Rating Scale (WSRS) scoring system which includes 5 scores:0- Absent.1- Slight wrinkles.2-Quite evident wrinkles.3-Evident wrinkles.4-Marked wrinkles.5-Very marked wrinkles. IBSA pharmeceutics Tehran University of Medical Sciences Paeezan Tejarat Mehr Approved 2020-10-12 Ethics committee of Tehran University of Medical Sciences vahdat islami square-vahdat islami street-razi hospital Tehran Tehran Iran (Islamic Republic of)