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IRCT20210515051307N1 IRCT 2021-11-14 Skin and Stem cell Research Center of Tehran University Investigation of the effect of stromal vascular fraction on burn scars Evaluation of the effectiveness and satisfaction of fractional carbon dioxide laser and stromal vascular fraction in comparison with laser alone in the treatment of burn scars 2021-08-23 anticipated 10 Complete https://irct.ir/trial/56337 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 10 patients with inclusion and exclusion criteria are selected. In each patient by simple randomization method, one burn scar is selected as the intervention group and another scar of the same patient is selected as the control group. For each burn scar, one envelope is randomly selected from two sealed envelopes . The letter a or b is written on each envelope. Envelopes a belong to the intervention group and envelopes b belong to the control group. The patient does not know to which group each envelope is assigned, Blinding description: In this study, the patient is unaware of the type of intervention performed on each burn scar.To blind the patient, a paper cover with the patient's name is attached on the body of the injection syringes .The outcome assessor is a dermatologist who has only images and biometric information of each scar for Vancouer scoring and he does not know the type of intervention.The data analyzer also is a statistician who has only the data to analyze and is not aware of the type of intervention. 2-3 Burn scars. Intervention 1: Intervention group: Patients will receive three sessions of fractional carbon dioxide laser treatment at one-month intervals. Deka fractional carbon dioxide laser device will be used to perform the laser treatment. Its setting will be determined based on the thickness of the scar and the patient's skin type. At the end of the first and third sessions of laser treatment, the Stromal vascular fraction injection will be performed in one of the patients' scars. To prepare it, depending on the required amount and the doctor's diagnosis, between 120 and 200 ccs of fat is drawn from the patient's side or abdomen. Then, after centrifugation and processing, the stromal vascular fraction is isolated. It will be injected into the scar with an insulin syringe. Intervention 2: Control group: Patients will receive three sessions of fractional carbon dioxide laser treatment at one-month intervals. Deka fractional carbon dioxide laser device will be used to perform the laser treatment. Its setting will be determined based on the thickness of the scar and the patient's skin type. At the end of the first and third sessions of laser treatment, in another scar of the patient as the control group, 5cc of the physiological serum will be injected with an insulin syringe. 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 more information.
public Fariba Khodadad
Rasoul Akram Hospital,Niayesh St.Sattar Khan St.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 1719 f.khodadad1991@gmail.com Iran University of Medical Sciences scientific Fariba Khodadad
Rasoul Akram Hospital,Niayesh St.Sattar Khan St.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 1719 f.khodadad1991@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients with skin type 1-4 Patients with atrophic burn scars in more than one limb, from five years ago to the last 3 months 18 years no limit Both Age under 18 years Patients who have received laser treatment in the last three months Patients with active colloidal scar or active skin lesion at the injection site Patients with coagulation and platelet disorders or a history of taking anticoagulants. Patients with a history of underlying diseases such as diabetes and autoimmune connective tissue disease that affect the wound healing process Patients with active viral infections History of malignancy or receiving chemotherapy Pregnancy and lactation L90.5 Scar conditions and fibrosis of skin Treatment - Other Treatment - Other Intervention group: Patients will receive three sessions of fractional carbon dioxide laser treatment at one-month intervals. Deka fractional carbon dioxide laser device will be used to perform the laser treatment. Its setting will be determined based on the thickness of the scar and the patient's skin type. At the end of the first and third sessions of laser treatment, the Stromal vascular fraction injection will be performed in one of the patients' scars. To prepare it, depending on the required amount and the doctor's diagnosis, between 120 and 200 ccs of fat is drawn from the patient's side or abdomen. Then, after centrifugation and processing, the stromal vascular fraction is isolated. It will be injected into the scar with an insulin syringe. Control group: Patients will receive three sessions of fractional carbon dioxide laser treatment at one-month intervals. Deka fractional carbon dioxide laser device will be used to perform the laser treatment. Its setting will be determined based on the thickness of the scar and the patient's skin type. At the end of the first and third sessions of laser treatment, in another scar of the patient as the control group, 5cc of the physiological serum will be injected with an insulin syringe. The effectiveness of treatment. Timepoint: Before starting the trial, before the second and third sessions of treatment with laser and two months after the last session. Method of measurement: Photography and biometry of the burn scars will be done. The scoring of the scars will be performed based on the Vancouver scoring system. Patient satisfaction from treatment. Timepoint: Two months after the last session of treatment with laser. Method of measurement: Patient global assessment score. Physician satisfaction from treatment. Timepoint: Two months after the last session of treatment with laser. Method of measurement: Physician global assessment score. Iran University of Medical Sciences Skin and Stem cell Research Center of Tehran University Iran University of Medical Sciences Approved 2021-05-08 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmeat Highway Tehran Tehran Iran (Islamic Republic of) Approved 2021-11-12 Ethics Committee of Tehran University of Medical Sciences Keshavarz Boulevard - Intersection of Ghods Street - Central Building of Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)