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IRCT20221012056155N1 IRCT 2023-01-29 Iran University of Medical Sciences A randomized controlled double-blinded clinical trial Evaluation of the effectiveness of autologous fat transfer on the quality of burn-induced scars 2022-12-31 anticipated 20 Complete https://irct.ir/trial/67827 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Every patient will be coded with the letter A or B using sealed envelopes. Each scar will be divided into two halves: A will be right or Up and B means left or down half. Group A will be injected with fat in right or upside half of the targeted scar and injected with normal saline in the left or downside half of the targeted scar. Group B will be injected with fat in the left or downside half of the targeted scar and injected with normal saline in the right or upside half of the targeted scar, Blinding description: The people listed below will be kept blind to the treated halves until the end of data collection: Main researcher The clinical investigator evaluates patients before the procedure and the Physicians who evaluate the outcomes Clinical care providers after the procedure Participants. N/A Condition 1: Scars. Condition 2: Burn of head, face, and neck sequela. Condition 3: Burn of trunk sequela. Condition 4: Burn of limbs sequela. Condition 5: Burn of Lower Limb sequela. Condition 6: hypertrophic scar. Intervention 1: First, the subcision and release of adhesions in the subdermal area of the specified location for fat injection are performed with a standard blunt cannula with a diameter of 1.5 mm. Autologous fat is harvested by Coleman's standard technique (with a 10 ml syringe connected to a blunt cannula with a diameter of 3 having several side holes at the end with a diameter of 2 mm) from the abdomen or side or medial thigh and then separating the fat by transferring it through a standard connector. 3 mm disposable syringe to a 2.5 ml syringe and placed in a centrifuge for 3 minutes with a rotation rate of 1200 rpm, and then the oil collected on the syringes and the bloody liquid contained at the bottom Syringes are thrown away. A standard 3 mm disposable connector transfers the separated fat to a 1 ml syringe with a lower lock. And in the marked half of the scar, using this 1 ml syringe connected to a blunt cannula with a diameter of 0.7 ml with a hole (Spon Tip), fat injection is performed under the scar at the rate of 0.4 ml per square centimeter in the subdermal area. Intervention 2: Control group: First, subcision and release of adhesions of the semi-scarred subdermal area are performed for normal saline injection with a blunt standard cannula with a diameter of 1.5 mm. Then, normal saline injection with a volume equal to the injected fat is performed in the subdermal area using a 1 ml syringe connected to a blunt cannula with a diameter of 0.7 with a hole (Spoon Tip). 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 There is no further information
public Seyyed-ehsan Mousavi-lajimi
َApt 7, No 10, Abtahi St, Kordestan Exp, Tehran, Iran
tehran Iran (Islamic Republic of) 1437633583 +98 21 8835 1450 s.ehsan.mousavi@gmail.com Iran University of Medical Sciences scientific Seyed-Ehsan Mousavi-Lajimi
َApt 7, No 10, 20th Kordestann Exp., Tehran, Iran
Tehran Iran (Islamic Republic of) 1437633583 +98 21 8835 1450 s.ehsan.mousavi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Burn-induced scars anywhere on the trunk or limbs or face or neck The minimal interval between burn injury and intervention(fat grafting) should not be less than one year(Mature Scars) 18 years 60 years Both Any significant systemic disease or morbidity ( e.g. Cardiac disease, Endocrine disease, Respiratory Disease etc) Any patient with an American Society of Anesthesiologist Physical Status Classification System score>II indicating increased anesthesia risk Low Body Mass Index (BMI) (Less than 19kg/m²) Known Systemic Immune Disorder (Acquired or inherited immune deficiency) L90.5 T20.00XS T21.00XS T22.00XS T24.009S L91.0 Scar conditions and fibrosis of skin Burn of unspecified degree of head, face, and neck, unspecified site, sequela Burn of unspecified degree of trunk, unspecified site, sequela Burn of unspecified degree of shoulder and upper limb, except wrist and hand, unspecified site, sequela Burn of unspecified degree of unspecified site of unspecified lower limb, except ankle and foot, sequela Hypertrophic scar Treatment - Surgery Placebo First, the subcision and release of adhesions in the subdermal area of the specified location for fat injection are performed with a standard blunt cannula with a diameter of 1.5 mm. Autologous fat is harvested by Coleman's standard technique (with a 10 ml syringe connected to a blunt cannula with a diameter of 3 having several side holes at the end with a diameter of 2 mm) from the abdomen or side or medial thigh and then separating the fat by transferring it through a standard connector. 3 mm disposable syringe to a 2.5 ml syringe and placed in a centrifuge for 3 minutes with a rotation rate of 1200 rpm, and then the oil collected on the syringes and the bloody liquid contained at the bottom Syringes are thrown away. A standard 3 mm disposable connector transfers the separated fat to a 1 ml syringe with a lower lock. And in the marked half of the scar, using this 1 ml syringe connected to a blunt cannula with a diameter of 0.7 ml with a hole (Spon Tip), fat injection is performed under the scar at the rate of 0.4 ml per square centimeter in the subdermal area. Control group: First, subcision and release of adhesions of the semi-scarred subdermal area are performed for normal saline injection with a blunt standard cannula with a diameter of 1.5 mm. Then, normal saline injection with a volume equal to the injected fat is performed in the subdermal area using a 1 ml syringe connected to a blunt cannula with a diameter of 0.7 with a hole (Spoon Tip). Overall Scar Score (Observer). Timepoint: Before intervention and three months after intervention. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. Overall Scar Score (Patient). Timepoint: Before intervention and three months after intervention. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. Scar Vascularity. Timepoint: Before interventions and three months after intervention. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. Scar Pigmentation (Observer Score). Timepoint: Before interventions and three months after intervention. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. Scar Thickness (Observer Score). Timepoint: Before interventions and three months after intervention. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. Scar Relief (Observer Score). Timepoint: Before interventions and three months after intervention. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. Scar Pliability (Observer Score). Timepoint: Before interventions and three months after intervention. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. Scar Surface Area. Timepoint: Before interventions and three months after intervention. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. Scar Pain. Timepoint: Before interventions and three months after intervention. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. Scar Itching. Timepoint: Before interventions and three months after intervention. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. Scar Color Difference (Patient Score). Timepoint: Before interventions and three months after intervention. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. Scar Stiffness (Patient Score). Timepoint: Before interventions and three months after intervention. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. Scar Thickness (Patient Score). Timepoint: Before interventions and three months after intervention. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. Scar Irregularity (Patient Score). Timepoint: Before interventions and three months after intervention. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. Iran University of Medical Sciences Approved 2022-12-31 Research Ethics Committees of School of Medicine, Iran University of Medical Sciences 21st St, Yousef Abad St, District 6, Tehran, Fatemeh Hospital Tehran Tehran Iran (Islamic Republic of)