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IRCT20210303050559N1 IRCT 2022-12-03 Shiraz University of Medical Sciences Nanofat in fine facial wrinkles Investigation the effect of injection of nanofat for correction of fine facial wrinkles 2021-03-10 anticipated 15 Complete https://irct.ir/trial/54744 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Other. N/A Facial wrinkles. Intervention group: The effect of nano-fat injection in correcting fine facial wrinkles in patients over 40 years old with facial wrinkles referred to the skin department of Faghihi Hospital in Shiraz, any area with excess fat deposits is selected as a donor site. Surface injection of 2% lidocaine is performed with a 27G fine needle at the cannula entry points.Any area with excess fat deposits is selected as a donor site. Surface injection of 2% lidocaine is performed with a 27G fine needle at the cannula entry points. The infiltration cannula is a 3 mm diameter blunt-tipped device with many side openings attached to a 10 or 20 cc syringe. Fat (about 10 cc) after infiltration, mostly from the lower abdomen (or thigh) was removed with about 250 cc of swelling solution containing 1 mg of epinephrine 1:1000, 1000 cc of 0.9% normal saline and 25 ml of 2% lidocaine. will be The harvested fat is filtered through a sterile 0.5 mm pore size filter and then transferred between two 10 cc syringes connected to each other by a female-to-female luer-lok connector. After about 30 passes, the fat turns into an emulsion.At the end of the fragmentation process, the fat is liquefied and easily passes through the sharp needle (27G). The patient's face is anesthetized with topical lidocaine, and the processed fat is injected into the fine wrinkles. Patients are evaluated before, immediately after and 3 months after treatment. In each visit, we take pictures from the front, left and right with Visioface 1000D (Electronic CK, made in Germany). This device has the ability to measure volume, area and depth as three specified parameters of wrinkles that are quantitatively compared before and after treatment. Also, the side effects of fat grafting, such as erythema, edema, ecchymosis, and infection, will be explained to patients.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Because in my RCT, personal data is not important and doesnt change the outcome
public Farzaneh akbari
Dermatology clinic, Faghihi hospital, zand street, shiraz
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3231 9049 Farzane.akbarii@gmail.com Shiraz University of Medical Sciences scientific Farzane Akbari
Dermatology clinic, faghihi hospital, zand street, shiraz
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3231 9049 Farzane.akbarii@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Having fine facial wrinkles in forehead area 30 years 65 years Both Having history of facial trauma Co-morbidities Botox injection 6 months before and 7 months after procedure Previous operation for facial wrinkles Filler injection for the facial wrinkles Treatment - Other Intervention group: The effect of nano-fat injection in correcting fine facial wrinkles in patients over 40 years old with facial wrinkles referred to the skin department of Faghihi Hospital in Shiraz, any area with excess fat deposits is selected as a donor site. Surface injection of 2% lidocaine is performed with a 27G fine needle at the cannula entry points.Any area with excess fat deposits is selected as a donor site. Surface injection of 2% lidocaine is performed with a 27G fine needle at the cannula entry points. The infiltration cannula is a 3 mm diameter blunt-tipped device with many side openings attached to a 10 or 20 cc syringe. Fat (about 10 cc) after infiltration, mostly from the lower abdomen (or thigh) was removed with about 250 cc of swelling solution containing 1 mg of epinephrine 1:1000, 1000 cc of 0.9% normal saline and 25 ml of 2% lidocaine. will be The harvested fat is filtered through a sterile 0.5 mm pore size filter and then transferred between two 10 cc syringes connected to each other by a female-to-female luer-lok connector. After about 30 passes, the fat turns into an emulsion.At the end of the fragmentation process, the fat is liquefied and easily passes through the sharp needle (27G). The patient's face is anesthetized with topical lidocaine, and the processed fat is injected into the fine wrinkles. Patients are evaluated before, immediately after and 3 months after treatment. In each visit, we take pictures from the front, left and right with Visioface 1000D (Electronic CK, made in Germany). This device has the ability to measure volume, area and depth as three specified parameters of wrinkles that are quantitatively compared before and after treatment. Also, the side effects of fat grafting, such as erythema, edema, ecchymosis, and infection, will be explained to patients. Depth of facial wrinkles. Timepoint: Before fat injection and 7 month later. Method of measurement: Using a device, visioface 1000D (ck electronic, manufactured in germany). Volume of facial wrinkle. Timepoint: Before fat injection and 7 month later. Method of measurement: Using a device, visioface 1000D (ck electronic, manufactured in germany). Area of facial wrinkle. Timepoint: Before fat injection and 7 month later. Method of measurement: Using a device, visioface 1000D (ck electronic, manufactured in germany). Decreasing the depth of facial wrinkle. Timepoint: Before the fat injection and 7 month later. Method of measurement: Using a device, visioface 1000D ( ck electronic, manufactured in germany). Decreasing the volume of facial wrinkle. Timepoint: Before the fat injection and 7 month later. Method of measurement: Using a device, visioface 1000D ( ck electronic, manufactured in germany). Decreasing the area of facial wrinkle. Timepoint: Before the fat injection and 7 month later. Method of measurement: Using a device, visioface 1000D ( ck electronic, manufactured in germany). Shiraz University of Medical Sciences Approved 2019-04-22 Ethics committee of Shiraz University of Medical Sciences University of medical science, zand street, shiraz shiraz Fars Iran (Islamic Republic of)