Comparison of the effect of Mitomycin C and triamcinolone injection on Hypertrophic scars in burn patients in Ahwaz city

Comparison of the effect of mitomycin c and triamcinolone injection on hypertrophic scars in burn patients in Ahwaz city

Patients with a 1:1 ratio will be placed in two groups receiving mitomycin C with a concentration of 0.4 mg/d and triamcilonone. This study will be conducted in a triple-blind manner, so that the patients, the researcher, and the supervisor were not aware of the grouping of the patients and the medication received by them. In such a way that the drugs are completely similar in terms of shape, color, smell.

This is a clinical trial study that will be conducted in Taleghani Hospital, Ahvaz, Iran between 2022 and 2023. This study will be conducted as a three-way blind, so that the participants, the researcher, and the Data and Safety Monitoring Board (DSMB) will not know the type of intervention allocated. Finally, patients with hypertrophic burn scar complications are divided into two groups. The first group will be received mitomycin C and the second group will be received triamcilonone. After that, in a period of two months, patients will be evaluated in both places in terms of reducing the size of scar and keloid, as well as in terms of color change, vascularity, flexibility, width based on Vancouver criteria and local itching.

Inclusion criteria: Patients with burns and needing injections Exclusion criteria: • 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

- Intervention group: recipient of mitomycin C with a concentration of .4 mg/d, one dose, manufactured by KOREA UNITED PHARM - Control group: Control group: Triamcinolone, 3 doses, two weeks apart for every dose, 1 mg, produced by Alborz Daru Company

Hypertrophic Scars

• 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.

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

Only the results related to the outcome and output of the intervention can be published. It is provided to researchers for further research.

The data will be available after the publication of the article.

Researchers working in academic and scientific institutions

In meta-analysis studies and conducting similar studies

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.

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.