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IRCT20120410009431N4 IRCT 2022-11-21 Iran University of Medical Sciences Comparison of the effects of triamcinolone and bleomycin on burn wounds Comparison of the effects of triamcinolone and bleomycin on hypertrophic scars caused by body burns 2022-12-22 anticipated 35 Complete https://irct.ir/trial/66879 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups. To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks. For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block 4, we divide patients into groups. 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC, Blinding description: In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B. 3 burn. Intervention 1: Intervention group: For each patient, two adjacent or non-adjacent areas in the body are randomly selected for intralesional injection (triamcinolone). The selected burn size is between 5 and 10 square centimeters. The injection site for triamcinolone is clearly defined so that they are not confused in future injections. The maximum dose of triamcinolone (manufactured by Exir company) is 40 mg per period. The injection is performed using a #27 needle under sedation in the operating room. All patients will be taken quality pictures with a camera at the beginning of the study and at the end of the fourth month to be compared by two plastic surgeons. Intervention 2: Control group:For each patient, two adjacent or non-adjacent areas in the body are randomly selected for intralesional injection (bleomycin). The selected burn size is between 5 and 10 square centimeters. The injection site for bleomycin is clearly defined so that they are not confused in future injections. The maximum dose of bleomycin (manufactured by Exir company) is 10 units per period. The injection is performed using a #27 needle under sedation in the operating room. All patients will be taken quality pictures with a camera at the beginning of the study and at the end of the fourth month to be compared by two plastic surgeons. 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 Its release schedule is not yet known
public Siamak Farokh Forghani
16 Azar street, Keshavarz avenue
Tehran Iran (Islamic Republic of) 8874113911 +98 21 8670 5503 siamakfarokh@yahoo.com Iran University of Medical Sciences scientific Siamak Farokh Forghani
16 Azar street, Keshavarz avenue
Tehran Iran (Islamic Republic of) 8874113911 +98 21 8670 5503 siamakfarokh@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Burn patients two months after recovery no limit no limit Both Patient dissatisfaction Hypersensitivity to triamcinolone or bleomycin M61.3 Calcification and ossification of muscles associated with burns Treatment - Drugs Treatment - Drugs Intervention group: For each patient, two adjacent or non-adjacent areas in the body are randomly selected for intralesional injection (triamcinolone). The selected burn size is between 5 and 10 square centimeters. The injection site for triamcinolone is clearly defined so that they are not confused in future injections. The maximum dose of triamcinolone (manufactured by Exir company) is 40 mg per period. The injection is performed using a #27 needle under sedation in the operating room. All patients will be taken quality pictures with a camera at the beginning of the study and at the end of the fourth month to be compared by two plastic surgeons. Control group:For each patient, two adjacent or non-adjacent areas in the body are randomly selected for intralesional injection (bleomycin). The selected burn size is between 5 and 10 square centimeters. The injection site for bleomycin is clearly defined so that they are not confused in future injections. The maximum dose of bleomycin (manufactured by Exir company) is 10 units per period. The injection is performed using a #27 needle under sedation in the operating room. All patients will be taken quality pictures with a camera at the beginning of the study and at the end of the fourth month to be compared by two plastic surgeons. Scar size. Timepoint: Four months after injection. Method of measurement: Using a ruler. Pain in the injection area. Timepoint: After injection. Method of measurement: Visual Analogue Scale. Injection site inflammation. Timepoint: After injection. Method of measurement: Observation. Iran University of Medical Sciences Approved 2020-04-21 Ethics committee of Iran University of Medical Sciences Hemat Highway next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)