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IRCT20201205049601N1 IRCT 2020-12-16 Artesh University of Medical Sciences Evaluating the efficacy of Losartan ointment in wound healing Evaluating the efficacy of Losartan ointment (an Angiotensin II Type I Receptor) in wound healing and preventing hypertrophic scars and keloids formation (useful in the injured military soldiers ) 2021-02-03 anticipated 24 Complete https://irct.ir/trial/52751 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this double-blinded, parallel clinical trial, the block randomization method will be used using 4,6, and 8 block sizes. First, the patient's scar will be categorized into two groups (left and right). Then one side, for example, the right side, will be considered as a reference site. The intended treatment (Losartan ointment) will then be allocated using the block randomization method to the reference site. For example, if treatment (Losartan ointment) is allocated to the right side, the placebo will be automatically allocated to the left side. The following website will be used for generating a list of randomized interventions: https://www.sealedenvelope.com/simple-randomiser/v1/lists The allocation will be concealed using the sealed envelopes, Blinding description: Each Losartan and placebo ointment will be defined with a specific code. The ointments will be placed in the same shape, and colored bottles, and the specific code will be attached to the bottles. Each time we will ask the patients to use each placebo and Losartan cream in a specific place twice a day for six months. Neither patient, caregivers, including nurses, nor doctors will know which cream (Placebo or drug) is administered in each site. The data will be collected using the Vancouver scar scale by doctors who had been blind to which drug is administered in each site. The corresponding researcher, the person who analysis the data and prepare the first draft of the article will not be blinded. 3 wound healing and preventing hypertrophic scars and keloids formation. Intervention 1: Intervention group: First a patient's scar will be categorized into two similar groups (Left and side). A Part of the scar selected randomly will be treated with Losartan ointment. The 5% Losartan ointment will be defined with a specific code. The ointment is going to be made by dissolving Losartan powder in a solvent including propanol and water and then mixed with eucerin to reach 100 mg weight. The patients will be asked to use 5% Losartan ointment tropically in the specified places twice a day every 12 hours for six continuous months. Intervention 2: Control group: First a patient's scar will be categorized into two similar groups (Left and side). A Part of the scar selected randomly will be treated with Placebo. The placebo consists of the solvent, including propranolol and water, and then mix it with eucerin to reach 100 mg weight and will not contain Losartan powder. The patients will be asked to use a 5% Losartan ointment tropically in the specified places twice a day every 12hours for six continuous months. 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 is available yet.
public Behzad Khodai
Unit 763, 2nd Floor, next to Hall Paradis, Vahidiyeh station, Damavand Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1644818411 +98 21 7769 4460 khodaibehzad@gmail.com Artesh University of Medical Sciences scientific Behzad Khodai
Unit 763, 2nd Floor, next to Hall Paradis, Vahidiyeh station, Damavand Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1644818411 +98 21 7769 4460 khodaibehzad@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) The patient’s scar length should be more than 10 centimeter, or they should have several scars with total length of 10 centimeter. The patient’s age should be between 18 to 50 years old. 18 years 50 years Both The patients who did not regularly consume ointments will be excluded. The patients who are pregnant, consume antihypertensive drugs, or have history of cancer, allergy and bleeding or discharge at scar site will be excluded. L91.0 Hypertrophic scar Treatment - Drugs Placebo Intervention group: First a patient's scar will be categorized into two similar groups (Left and side). A Part of the scar selected randomly will be treated with Losartan ointment. The 5% Losartan ointment will be defined with a specific code. The ointment is going to be made by dissolving Losartan powder in a solvent including propanol and water and then mixed with eucerin to reach 100 mg weight. The patients will be asked to use 5% Losartan ointment tropically in the specified places twice a day every 12 hours for six continuous months. Control group: First a patient's scar will be categorized into two similar groups (Left and side). A Part of the scar selected randomly will be treated with Placebo. The placebo consists of the solvent, including propranolol and water, and then mix it with eucerin to reach 100 mg weight and will not contain Losartan powder. The patients will be asked to use a 5% Losartan ointment tropically in the specified places twice a day every 12hours for six continuous months. Scare assessment, Vancouver Scar Scale (VSS) assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. The overall score is between 0 to 13. Timepoint: Three and six months after ointment administration. Method of measurement: The evaluators are doctors who will use VSS or Vancouver scar scale to rate the scar change. Vancouver Scar Scale (VSS) assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. The overall score is between 0 to 13. Itching is an irritating sensation of the skin which will be measured by the Visual Analogue Scale. Timepoint: Three and six months after ointment administration. Method of measurement: The evaluators are doctors and will be measured by the Visual Analogue Scale. Artesh University of Medical Sciences Approved 2020-11-15 AJA University of Medical Sciences AJA University of Medical Sciences, Etemad Zadeh St. ,Fatemi Ave. ,Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)