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IRCT20230212057391N1 IRCT 2023-04-10 Ahvaz University of Medical Sciences Mitomycin C on Hyettrophic scars in comparison with triamcinolone injection in burn patients Comparison of the effect of Mitomycin C and triamcinolone injection on Hypertrophic scars in burn patients in Ahwaz city 2023-02-20 anticipated 90 Complete https://irct.ir/trial/68547 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: • Randomization method and description of each method: block of 4 • Randomization unit: individual • Randomization tool: Web-based randomization (https://www.sealedenvelope.com/), sealed envelope • How to make a random sequence: Randomization will be done on the web (https://www.sealedenvelope.com). After selecting Create list, it specifies the number of groups, block size and length of the list and based on that, it provides the randomization list. • Explanation of allocation concealment: Sealed envelopes that are assigned to each participant upon entering, based on which they will be placed in one of the two groups, Blinding description: Patients with equal to ratio are placed in two groups receiving mitomycin C with a concentration of .4 mg/dose and triamcilonone. This study is done in a three-way blind way, so that the patient, the researcher and the observer will not have any information about which group the people will be placed in and what medicine they will receive. In this way, the medicines will be completely similar in terms of shape, color, smell. In such a way that it is not clear for the patient, the researcher and the observer who receives what medicine. 3 Burn. Intervention 1: Intervention group: recipient of mitomycin C with a concentration of .4 mg/d, one dose, manufactured by KOREA UNITED PHARM. Intervention 2: Control group: Control group: triamcilonone, 3 doses, two weeks apart for every dose, 1 mg, produced by Alborz Daru Company. Yes - There is a plan to make this available What will be shared: Only the results related to the outcome and output of the intervention can be published. It is provided to researchers for further research. When: The data will be available after the publication of the article. To whom: Researchers working in academic and scientific institutions Conditions: In meta-analysis studies and conducting similar studies Where to obtain: Refer to the Research and Technology Vice-Chancellor of Jundishapur University of Medical Sciences. While submitting the proposal and obtaining the code of ethics from the ethics committee of this university, access to the data should be provided for the researchers. How to obtain: Researchers can have access to data through correspondence with the vice president of research and technology of the university and since obtaining the code of ethics from the research ethics committee of Ahvaz University of Medical Sciences. Comments:
public Abdulreza Sheikhi
Farvardin Blvd
Ahvaz Iran (Islamic Republic of) 6135733118 009861337430011 sheikhi-a@ajums.ac.ir Ahvaz University of Medical Sciences scientific Jafar Jafarzadeh
Ahvaz, Taleghani Hospital
Ahvaz Iran (Islamic Republic of) 61339 11151 +98 61 3554 0256 drj.jafarzadeh1983@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients with burns and needing injections Patients over 18 years old 18 years no limit Both • Pregnant women and nursing mothers • People with mental problems • Inability to write or read Farsi • Prisoners • People who do not want to participate in the study T20 Burn and corrosion of head, face, and neck Treatment - Drugs Treatment - Drugs Intervention group: recipient of mitomycin C with a concentration of .4 mg/d, one dose, manufactured by KOREA UNITED PHARM Control group: Control group: triamcilonone, 3 doses, two weeks apart for every dose, 1 mg, produced by Alborz Daru Company Hypertrophic scars. Timepoint: In a period of 2 months at the beginning of the study and 2 months after the injection. Method of measurement: Measurement is done with a ruler. Ahvaz University of Medical Sciences Approved 2022-11-15 Ethics committee of Golestan hospital, Ahvaz University of Medical Sciences Farvardin Blvd Ahvaz Khouzestan Iran (Islamic Republic of)