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IRCT20221130056672N3 IRCT 2024-01-10 Tehran University of Medical Sciences Characterization and evaluation of the safety and effectiveness of human umbilical cord blood serum alginate hydrogel on patients with 2A degree burns. Characterization and evaluation of the safety and effectiveness of human umbilical cord blood serum alginate hydrogel on patients with 2A degree burns(Phase 1 clinical trial) 2024-03-05 anticipated 30 Complete https://irct.ir/trial/74801 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using a simple randomization method, patients who come to Motahari Hospital with 2A degree burns are placed in 2 groups of 15 people, so that one envelope is randomly selected for each patient from the number of 30 sealed envelopes. The letters A and B are inserted inside each envelope. Group A patients will be treated with 1% silver sulfadiazine ointment and group B will be treated with cord blood serum alginate hydrogel. 1 2A degree burns. Intervention 1: Intervention group: Treated with human cord blood serum alginate hydrogel is placed as a layer with a diameter of 5 mm on the 2A degree burn wound and it is bandaged every other day for up to 14 days. Intervention 2: Control group: Treated with 1% silver sulfadiazine ointment along with a simple hydrogel dressing that is bandaged every other day for up to 14 days. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals. When: Six months after the publication and printing of the article To whom: Academic researchers and experts Conditions: In order to analyze the results of the study outcomes Where to obtain: etaghiabadi@sina.tums.ac.ir How to obtain: It can be submitted after review by the Research Council of the Skin and Stem Cell Research Center of Tehran University of Medical Sciences, which usually takes 2 to 3 months. Comments:
public Ehsan Taghiabadi
No. 4 , 4th floor, Maryam dead end, South Kamraniyeh
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7438 etaghiabadi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Ehsan Taghiabadi
No. 4 , 4th floor, Maryam dead end, South Kamraniyeh
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7438 etaghiabadi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Men and women aged 18 to 60 who have 2A degree burns with a burn percentage of less than 15% of the body surface. The dimensions of the burn wound should be 10 x 10 cm. Willingness to participate in research and able to answer questions. 18 years 60 years Both Have underlying diseases and immune system defects such as diabetes, cancer, AIDS, high blood pressure and skin allergies. Before entering the sample into the research, they have used a substance other than drinking water on the wound. A person with symptomatic infection in different parts of the body. Burns in the face and genital area. More than 48 hours have passed from the time of the burn to the time of entering the study. According to the doctor's opinion, the person needs to be hospitalized. T30.2 Burn of second degree, body region unspecified Treatment - Other Treatment - Other Intervention group: Treated with human cord blood serum alginate hydrogel is placed as a layer with a diameter of 5 mm on the 2A degree burn wound and it is bandaged every other day for up to 14 days. Control group: Treated with 1% silver sulfadiazine ointment along with a simple hydrogel dressing that is bandaged every other day for up to 14 days. Healing time. Timepoint: Measurement of healing time on days 0 (before the intervention), 7 and 14. Method of measurement: Photography with Image J software. The amount of pain. Timepoint: Pain measurement on days 0 (before the start of the intervention), 7 and 14. Method of measurement: questionnaire survey (Patient self-report). Tehran University of Medical Sciences Approved 2023-12-13 Research Ethics Committees of Research Institute for Oncology, Hematology and Cell Therapy - Tehran Shariati Hospital, North Kargar Street, Tehran Tehran Tehran Iran (Islamic Republic of)