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IRCT20180221038821N5 IRCT 2023-02-05 Gonabad University of Medical Sciences Comparison of the effect of sesame oil and 1% silver sulfadiazine ointment on the pain, healing and scarring of burn wounds Comparison of the effect of sesame oil and 1% silver sulfadiazine ointment on the pain, healing and scarring of burn wounds 2023-01-21 anticipated 40 Complete https://irct.ir/trial/68252 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were first selected by the available method and then divided into two groups of sesame oil and silver ointment by using 4 permutation blocks. In this method, the sesame oil group was coded with the letter A and the silver ointment group was coded with the letter B. The six possible states in the blocks included ABAB, BBAA, AABB, BABA, AAAA, BBBB, and each block was assigned a number. For every four selected people, a number will be selected according to the list, and people will be assigned to two groups of sesame oil and silver ointment in this way, Blinding description: The emergency medicine doctor who will confirm the recovery of the patients will not know about the grouping of the patients. The data analyst will also be unaware of the grouping of patients. 3 Burn. Intervention 1: Intervention group: Sesame oil group: For the sesame oil group, the burn wound dressing with sesame oil will first be washed with sodium chloride for washing and exposed to the open air for 5 minutes until it dries completely. Then, the wound area is smeared with 2 ml of sesame oil (for 10 square centimeters of the wound) and the surface of the wound is covered with freezer plastic (to absorb more sesame oil) and then it will be bandaged. Sesame oil used in this notice will be completely natural and without preservatives with standard devices from a local store and will be prepared under supervision. It should be noted that this extract is 100% oily and in addition to being free of water molecules, it also contains antimicrobial compounds that prevent the growth of microbial agents in this extract. Nevertheless, in order to ensure the negativity of the microbial culture, random samples of the extract prepared in the microbial culture media of blood agar, chocolate agar, eosin methylene blue, Kant agar plate, lauryl sulfate broth and selected culture media for the investigation of yeasts and fungi will be used. Intervention 2: Intervention group: Silversulfadiazine 1% group: Dressing the burn wound first, the wound area will be washed with normal saline for washing and exposed to the open air for 5 minutes until it dries completely. Then the wound will be smeared with 1% silver sulfadiazine ointment and covered with freezer plastic and bandaged. One percent silver sulfadiazine ointment of Iran Najo Pharmaceutical Company will also be used for this group. 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 Sampling has not been done yet
public Iman Ghorbany Moghaddam
No9, Behesht Street, Emam Sajjad Blvd, Gonabad Town
Gonabad Iran (Islamic Republic of) 9691647161 +98 51 5722 0576 imanghorbany135213@gmail.com Gonabad University of Medical Sciences scientific Dr. Moosa Sajjadi
Asian Roads, Gonabad University of Medical Sciences
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 0576 sajjadi1975@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Informed consent to participate in the study Age 20-60 years First and second degree burns with an extent of 1-10% Burns due to contact with a heat source or liquids 20 years 60 years Both Sesame oil allergy Confirmation of the need for hospitalization of the patient by the doctor Taking painkillers and NSAIDs orally or topically until the first visit to the treatment center Background diseases such as anemia, diabetes, cardiovascular diseases, malignancy and immune system defects Abnormal hemoglobin and total protein More than 6 hours passed from the time of the burn to the time of going to the medical center Z73.0 Burn-out Treatment - Drugs Treatment - Drugs Intervention group: Sesame oil group: For the sesame oil group, the burn wound dressing with sesame oil will first be washed with sodium chloride for washing and exposed to the open air for 5 minutes until it dries completely. Then, the wound area is smeared with 2 ml of sesame oil (for 10 square centimeters of the wound) and the surface of the wound is covered with freezer plastic (to absorb more sesame oil) and then it will be bandaged. Sesame oil used in this notice will be completely natural and without preservatives with standard devices from a local store and will be prepared under supervision. It should be noted that this extract is 100% oily and in addition to being free of water molecules, it also contains antimicrobial compounds that prevent the growth of microbial agents in this extract. Nevertheless, in order to ensure the negativity of the microbial culture, random samples of the extract prepared in the microbial culture media of blood agar, chocolate agar, eosin methylene blue, Kant agar plate, lauryl sulfate broth and selected culture media for the investigation of yeasts and fungi will be used. Intervention group: Silversulfadiazine 1% group: Dressing the burn wound first, the wound area will be washed with normal saline for washing and exposed to the open air for 5 minutes until it dries completely. Then the wound will be smeared with 1% silver sulfadiazine ointment and covered with freezer plastic and bandaged. One percent silver sulfadiazine ointment of Iran Najo Pharmaceutical Company will also be used for this group. Wound healing time. Timepoint: After confirming the healing of the wound by an emergency medicine specialist. Method of measurement: Questionnaire (Day). The scar left by the wound. Timepoint: After confirming the healing of the wound by an emergency medicine specialist. Method of measurement: Beitz-Johnson Burn Wound Assessment Tool. Intensity of pain. Timepoint: Before and after dressing in the first session. Method of measurement: Visual pain scale. Gonabad University of Medical Sciences Approved 2022-12-24 Ethnical Committee of Gonabad University of Medical Sciences Asian Road Rim, Gonabad University of Medical Sciences Gonabad Razavi Khorasan Iran (Islamic Republic of)