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IRCT20201106049283N1 IRCT 2021-01-13 Bagheiat-allah University of Medical Sciences Evaluation of the effect of ZOUSH natural ointment on open wound healing due to surgery in patients with pilonidal sinus Evaluation of the effect of ZOUSH natural ointment on open wound healing due to surgery in patients with pilonidal sinus 2020-12-21 anticipated 70 Complete https://irct.ir/trial/52114 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups using statistical software and Permuted block randomization (With 4 and 6 numbers blocks)، The vital statistician arranges random groups and puts each random situation in an envelope, When each patient enters the study, an envelope is opened and his treatment group is identified. 3 Wounds from pilonidal sinus surgery. Intervention 1: Intervention group: To prepare Zoush herbal ointment, Zataria multiflora Boiss and Origanum vulgare plants is purchased from Barij Essence Herbal Medicine Center and the alcoholic extract is prepared, and finally the extracts are delivered in powder form from the same company. The composition of the extracts is measured using gas chromatography. The extracts dissolve 1/3 in dimethyl sulfoxide. Honey is dissolved in a 1/3 ratio in sterile distilled water. Polyurethane in a ratio of 1/3 is first dissolved in 6 M urea and then placed on indirect heat to evaporate the urea. Plant extracts, Zataria multiflora, and Origanum vulgare soluble in DMSO, water-soluble honey, and urea-soluble polyurethane are mixed one by one in a separate falcon and will be used as the initial stock of Zoush ointment in other stages. Intervention 2: Control group: Only water washing and baby shampoo are used without any effective ingredients. 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 Due to the fact that the information of the participants in this project is confidential, no decision has been made yet on whether or not to publish the participants' data file.
public Mahdi Mesgaranzade
Mollasadra
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8126 3582 mahdimesgaran@yahoo.com Bagheiat-allah University of Medical Sciences scientific Mahdi Mesgaranzade
Mollasadra
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8126 3582 mahdimesgaran@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients with primary pilonidal sinus who have undergone open surgery BMI less than 35 Conscious consent to participate in the project Males under 45 years 15 years 45 years Male Accompanying metabolic disorders including diabetes and uremic disorders Receive immunosuppressive drugs Treatment - Drugs Treatment - Other Intervention group: To prepare Zoush herbal ointment, Zataria multiflora Boiss and Origanum vulgare plants is purchased from Barij Essence Herbal Medicine Center and the alcoholic extract is prepared, and finally the extracts are delivered in powder form from the same company. The composition of the extracts is measured using gas chromatography. The extracts dissolve 1/3 in dimethyl sulfoxide. Honey is dissolved in a 1/3 ratio in sterile distilled water. Polyurethane in a ratio of 1/3 is first dissolved in 6 M urea and then placed on indirect heat to evaporate the urea. Plant extracts, Zataria multiflora, and Origanum vulgare soluble in DMSO, water-soluble honey, and urea-soluble polyurethane are mixed one by one in a separate falcon and will be used as the initial stock of Zoush ointment in other stages. Control group: Only water washing and baby shampoo are used without any effective ingredients. This clinical trial study will be performed to evaluate the restorative effect of ZOUSH on wounds caused by pilonidal sinus surgery in 70 patients referred to Baqiyatallah Hospital. Timepoint: Intervals 7 days, 14 days, and one month and three months after surgery. Method of measurement: During surgery after establishing dimensional homeostasis; the wound volume is measured by filling normal saline with a graduated syringe. The size of the wound. Timepoint: Study days 7, 14, 30 and 90. Method of measurement: BATES JENSIN Wound Questionnaire. Bagheiat-allah University of Medical Sciences Approved 2020-10-31 Ethics Committee of Baqiyatallah University of Medical Sciences Mollasadra street Tehran Tehran Iran (Islamic Republic of)