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IRCT20231122060138N1 IRCT 2023-12-03 Zanjan University of Medical Sciences Investigating effectiveness of smart biodegradable nanofiber dressing in the treatment of 2nd degree burn wounds Investigating the safety and effectiveness of smart biodegradable nanofiber dressing in the treatment of deep 2nd degree burn wounds (first and second phase of clinical trial) 2023-12-11 anticipated 16 Complete https://irct.ir/trial/74015 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, in order to assign patients to the intervention and control groups, the restricted randomization approach will be used in parallel with the Random Allocation Rule method. In the random assignment process, the person who creates the random sequence is the analyst in this study. Also, the person who registers the participants based on the entry and exit criteria in the study will be one of the clinic nurses, and the person who allocates the participants in the intervention and control groups will be the project manager, Blinding description: In order to blind the researcher and the patient, dressings that are similar in color and shape are used in the control and intervention areas. The analyzer is blinded based on the coding of the dressings. 1-2 Second degree burn. Intervention 1: Intervention group: Randomly, the site of the intervention group will be selected and will receive polymer dressing containing lactic acid and s-caprolactone. Intervention 2: Control group: A part of the burn wound of the patients is randomly selected and receives the original Suprathel dressing. No - There is not a plan to make this available Justification or reason for not sharing IPD is -
public Ahmadreza Mobayen
Department of Infectious Diseases, valiasr Hospital, Sheikh Fazlolah ave, Zanjan-Iran
Zanjan Iran (Islamic Republic of) - - amobaien@yahoo.com Zanjan University of Medical Sciences scientific Ahmadreza Mobayen
Department of Infectious Diseases, Valiasr Hospital, Sheikh Fazlolah ave, Zanjan-Iran
Zanjan Iran (Islamic Republic of) - - amobaien@yahoo.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Adult patient between 18 and 65 years old Refer to the treatment center in less than 24 hours Burn percentage ranges from 20-50% Fill out the informed consent form There should be at least 2 recorded records of the investigated variables. Patients should stay in the hospital for at least three days 18 years 65 years Both Having severe hypertension BP≥160/90 mmHg High cardiac troponin pregnant women Immune system defect Anticoagulation problems, bleeding disorders, or heart disease T20 Burn and corrosion of head, face, and neck Treatment - Other Treatment - Other Intervention group: Randomly, the site of the intervention group will be selected and will receive polymer dressing containing lactic acid and s-caprolactone. Control group: A part of the burn wound of the patients is randomly selected and receives the original Suprathel dressing Local outcomes. Timepoint: At the beginning of the study (before the intervention) and 1, 3, 7, 14 and 28 days after applying the wound dressing. Method of measurement: Clinical observations and filling the checklist in 6 time points. Systemic outcomes. Timepoint: At the beginning of the study (before the intervention) and 1, 3, 7, 14 and 28 days after applying the wound dressing. Method of measurement: Clinical observations and filling the checklist in 6 time points. Wound healing rate. Timepoint: At the beginning of the study (before the intervention) and 1, 3, 7,14, and 28 days after applying the wound dressing. Method of measurement: Based on examination done by evaluators. Zanjan University of Medical Sciences Approved 2023-10-31 The ethics committee of Zanjan University of Medical Sciences The ethics committee of Zanjan University of Medical Sciences, first floor, Northside of Azadi Boulevard, Zanjan. Zanjan Zanjan Iran (Islamic Republic of)