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IRCT201305168146N13 IRCT 2013-06-02 Shahid Beheshti University of Medical Siences Effect of 980 nm Diode laser lipolysis in submental area Comparison the efficacy and safety of the 980 nm Diode laser lipolysis and liposuction of submental area in shohada-Tajrish Hospital 2013-06-16 anticipated 40 Complete https://irct.ir/trial/8576 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Fat accumulation in submental area. Intervention 1: intervention group: patients with submental fat accumulation who undergot laser lipolysis On the day of procedure, the area of target treatment is marked. Then patients are prep and draped in sterile fashion. Local tumescent anesthesia is composed of 1000 cc sodium chloride 0.9%, 100 cc lidocaine 1%, and 1cc epinephrine 1:1000. A total tumescent of 200-300cc is delivered to the submental area. Upon delivery of tumescent, an incision of 1-3mm is created at the target treatment area for the introduction of cannula. The 980nm diode laser (pharaon,OSYRIS, hellemmes,France) is used in continuous emission mode with power of 6-8 W. Laser energy is transmitted using a 600µm optical fiber encased in a 1 mm diameter microcannula through the incision into the subcutaneous fat moving at the rate at least of 1cm/s. the microcannula is moved in a backward and forward fan-like motion in the horizontal plane to achieve homogenous distribution of the laser energy. The treated area is held by operator's hand to attenuate the resistance of tissue and manually measure the skin temperature. When laser energy delivery is complete, the liquefied fat was aspirated with a 3mm cannula. Intervention 2: control group(traditional liposuction)the patient’s neck is marked with permanent marker to delineate the area to be treated, including the submental fat pad. The primary cannula entry point is located in the mental crease, approximately 0.5 cm directly posterior to the posterior border of the mandible at the chin. Liposuction is performed under sterile technique. After being marked, the patient’s face, neck, and chest is cleansed with chlorhexidine. Local tumescent anesthesia is composed of 1000 cc sodium chloride 0.9%, 100 cc lidocaine 1%, and 1cc epinephrine 1:1000. A total tumescent of 200-300cc is delivered to the submental area. The cannula is inserted into entry sites with the tip apertures facing downward, away from the dermis, to avoid inadvertent removal of superficial fat. Tunneling with the cannula is performed in linear, even strokes with the surgeon’s dominant hand, with the non dominant hand, or “smart hand,” controlling cannula tip position at all times. Multiple consecutive passes are made in each tunnel with aspiration before moving to the next location.
public Neda Valizadeh
Shohada Tajrish Medical center, Tajrish Sq, Tehran,Iran
Tehran Iran (Islamic Republic of) +98 21 2274 9221 barikbinb@yahoo.com Laser application in medical research center,Shahid Beheshti University of medical sciences scientific Behrooz Barikbin
Shohad Tajrish medical center,Tajrish Sq, Tehran,
Tehran Iran (Islamic Republic of) +98 21 2274 9221 barikbinb@yahoo.com IranLaser application in medical sciences research center,Shahid beheshti university of medical scie Iran (Islamic Republic of) Female adults who express a desire for improving their submental contour were enrolled in this prospective randomized clinical trial. Patients with any previous treatment such as liposuction or lipolysis or in submental region were excluded from the study. Subjects with infection in the area, bleeding tendency,weight variation of more than 10% in the follow up evaluation, known allergy to local anesthetics, history of compromised wound healing, pregnancy and pregnancy were exluded. no limit no limit Female Treatment - Surgery Treatment - Drugs intervention group: patients with submental fat accumulation who undergot laser lipolysis On the day of procedure, the area of target treatment is marked. Then patients are prep and draped in sterile fashion. Local tumescent anesthesia is composed of 1000 cc sodium chloride 0.9%, 100 cc lidocaine 1%, and 1cc epinephrine 1:1000. A total tumescent of 200-300cc is delivered to the submental area. Upon delivery of tumescent, an incision of 1-3mm is created at the target treatment area for the introduction of cannula. The 980nm diode laser (pharaon,OSYRIS, hellemmes,France) is used in continuous emission mode with power of 6-8 W. Laser energy is transmitted using a 600µm optical fiber encased in a 1 mm diameter microcannula through the incision into the subcutaneous fat moving at the rate at least of 1cm/s. the microcannula is moved in a backward and forward fan-like motion in the horizontal plane to achieve homogenous distribution of the laser energy. The treated area is held by operator's hand to attenuate the resistance of tissue and manually measure the skin temperature. When laser energy delivery is complete, the liquefied fat was aspirated with a 3mm cannula. control group(traditional liposuction)the patient’s neck is marked with permanent marker to delineate the area to be treated, including the submental fat pad. The primary cannula entry point is located in the mental crease, approximately 0.5 cm directly posterior to the posterior border of the mandible at the chin. Liposuction is performed under sterile technique. After being marked, the patient’s face, neck, and chest is cleansed with chlorhexidine. Local tumescent anesthesia is composed of 1000 cc sodium chloride 0.9%, 100 cc lidocaine 1%, and 1cc epinephrine 1:1000. A total tumescent of 200-300cc is delivered to the submental area. The cannula is inserted into entry sites with the tip apertures facing downward, away from the dermis, to avoid inadvertent removal of superficial fat. Tunneling with the cannula is performed in linear, even strokes with the surgeon’s dominant hand, with the non dominant hand, or “smart hand,” controlling cannula tip position at all times. Multiple consecutive passes are made in each tunnel with aspiration before moving to the next location. Fat reduction in patients. Timepoint: Before ,one week,one month, three months later. Method of measurement: Ultrasonography. Objective assessment. Timepoint: Before, one week, one month, three months later. Method of measurement: Picturing the patients and assessment by blinded physician. Shahid Beheshti University of Medical Siences Approved 2010-05-02 Shahid Beheshti University of Medical Sciences Ethics Committee Daneshjoo Blvd., Velenjak st. Tehran Iran (Islamic Republic of)