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IRCT20190810044500N23 IRCT 2022-03-02 Yazd University of Medical Sciences the efficacy of topical erythropoietin treatment on healing of second degree burned cutaneous burned wounds the efficacy of topical erythropoietin treatment on healing of second degree burned cutaneous burned wounds 2022-04-21 anticipated 48 Complete https://irct.ir/trial/55887 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned to two groups of 24 controls or interventions by the permutation block method. Twelve blocks of four are considered. Generation of random codes using Permuted Block Randomization method will be done with the help of Random allocation software (version 1). The first person who is eligible to enter the study is given number one and likewise, the last eligible person is given number 48. By using the software-generated table, patients receive each intervention A or B (Each of the letters A and B will be installed on similar containers of the interventions). In order to consider blinding in random allocation, the list is given to another person outside the study and using short message service (SMS) before assigning the type of treatment according to the number of eligible people is asked and thus people enter the study, Blinding description: The steps will be covered from the perspective of the patient, the treating physician, and the assessors. The first presenter identifies the sequence of assignments of patients according to the order of entry of the patients into the study, and puts the erythropoietin and placebo creams (identical from color, odor, and shape) into one-size boxes for patient use, and identifies them with A or B codes. The student then delivers the drugs to each individual patient. 3 Burn. Intervention 1: Intervention group: Erythropoietin cream will be made in the Pharmaceutics Laboratory of Yazd School of Pharmacy. Patients with second-degree burns referred to Yazd Martyrs Hospital in Yazd will be included in the study. Patients will receive erythropoietin cream once a day for two weeks. Intervention 2: Control group: Placebo cream will be made in the Pharmaceutics Laboratory of Yazd School of Pharmacy. Patients with second-degree burns referred to Yazd Martyrs Hospital in Yazd will be included in the study. Patients will receive placebo cream once a day for two weeks. 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 No more information
public Fatemeh Saghafi
School of Pharmacy., Shahid Sadoughi university of medical sciences., Shohaday Gomnam blvd
Yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3419 F.saghafi@ssu.ac.ir Yazd University of Medical Sciences scientific Fatemeh Saghafi
School of Pharmacy., Shahid Sadoughi university of medical sciences., Shohaday Gomnam blvd
Yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3419 F.saghafi@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Presenting to the burn center in the first 24 hours after the burn Having grade II burns, superficial and deep, that involve less than 10% of the body's surface area No comorbidity that delays the repair process (such as diabetes, chronic kidney disease, malignancy, and chronic use of corticosteroids) Absence of respiratory burns as well as chemicals or electric burn No burns on the face and perineum and hand 18 years 60 years Both Concurrent infection during the study Lack of response to treatment The need for skin graft surgery L99 Other disorders of skin and subcutaneous tissue in diseases classified elsewhere Treatment - Drugs Placebo Intervention group: Erythropoietin cream will be made in the Pharmaceutics Laboratory of Yazd School of Pharmacy. Patients with second-degree burns referred to Yazd Martyrs Hospital in Yazd will be included in the study. Patients will receive erythropoietin cream once a day for two weeks. Control group: Placebo cream will be made in the Pharmaceutics Laboratory of Yazd School of Pharmacy. Patients with second-degree burns referred to Yazd Martyrs Hospital in Yazd will be included in the study. Patients will receive placebo cream once a day for two weeks. Mean time of wound healing. Timepoint: The wound healing process is measured during the study period on days 1, 3, 7, 10, 14, and 21 after starting to use Erythropoietin cream on the wound area. Method of measurement: Clinical examination. The rate of pigmentation. Timepoint: The rate of pigmentation is measured during the study period on days 1, 3, 7, 10, 14, and 21 after starting to use Erythropoietin cream in the wound area. Method of measurement: Clinical examination. The rate of pain. Timepoint: The rate of pain is measured during the study period on days 1, 3, 7, 10, 14, and 21 after starting to use Erythropoietin cream in the wound area. Method of measurement: Clinical examination. The rate of pruritus. Timepoint: The rate of pruritus is measured during the study period on days 1, 3, 7, 10, 14, and 21 after starting to use Erythropoietin cream in the wound area. Method of measurement: Clinical examination. Complications observed. Timepoint: End of the study. Method of measurement: Based on the doctor's observation and the person's statements. Yazd University of Medical Sciences Approved 2020-07-06 Ethics Commitee of Shahid Sadoughi University Medical Sciencrs Shahid Sadoughi university of medical sciences, Professor Hesabi Blvd, Yazd, Iran. Yazd Yazd Iran (Islamic Republic of)