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IRCT20220306054206N3 IRCT 2024-02-26 Esfahan University of Medical Sciences Investigating the effect of oral and topical Cicaglocal drug on wound healing Investigating the effect of oral and topical Cicaglocal drug on wound healing in patients after micrographically oriented histographic surgery (Mohs surgery) 2024-02-19 anticipated 48 Complete https://irct.ir/trial/75349 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize the samples, we give each drug a code and ask the patient to choose one of the codes by lottery, Blinding description: The placebo drug is prepared by the Persian Pod company based on the drugs and provided to the presenter. 4 drug groups including 2 groups for oral use and 2 groups for local use will be prepared, each group will include placebo and main drug. The same container as the original medicine is used to make the placebo medicine, and only its contents are changed to placebo, for the oral medicine in the capsule, starch is used, and for the topical medicine, the oil base used in the preparation of the original medicine is used. Therefore, both placebo and main drugs are completely similar in appearance. Then, each drug group is named with an English letter name, which in this plan, the oral drug is named S and K and the topical drug is named H and T, and it is given to the project manager. Therefore, the project manager and the patient do not know the type of the main drug, which is placebo or active drug. 1-2 Ulcer. Intervention 1: The intervention group includes oral capsule and topical solution of Sikaglocal. The patient receives one capsule daily for 2 weeks (14 capsules) and topical solution twice a day for 2 weeks (one vial of solution). The drug is prepared by Daru Darman Parshin Pod Company, whose main composition is bromelain and, along with other items, it includes vitamin C, group B vitamins including: B2, B3, B7, vitamin D, iron, zinc, copper, Centella plant extract, and sodium. Hyaluronate is combined. The medicine is stored at room temperature. In each session, the correct way to take the medicine is explained to the patient and the method of use is indicated on the product. Intervention 2: The control group includes oral capsules and placebo topical solution. The patient receives one capsule daily for 2 weeks (14 capsules) and topical solution twice a day for 2 weeks (one vial of solution). The drug is prepared by Daru Derman Parshin Pod Company, which is an oral capsule containing starch and an oil-based topical solution. The medicine is stored at room temperature. In each session, the correct way to take the medicine is explained to the patient and the method of use is indicated on the product. Yes - There is a plan to make this available What will be shared: All patient information can be shared because it includes age, gender, and type of disease, and the photos must be designed in such a way that it is not possible to identify people. When: After the article is printed, there is a place to publish the documents To whom: Researchers of academic and scientific centers have access to documents Conditions: The data should not be used directly and only for sampling and comparison with their own information. Where to obtain: Be in touch with the email of the main author of the article. How to obtain: After checking the applicant's email, he will have access within one month Comments:
public Parisa Mohammadian
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, central headquarters
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 parisa14m@yahoo.com Esfahan University of Medical Sciences scientific Parisa Mohammadian
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, central headquarters
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 parisa14m@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients who have undergone Mohs surgery due to skin cancer of the head and face Age should be in the range of 50 to 80 years. Completing the consent form to participate in the study 50 years 80 years Both Surgery in an area of ​​the body other than the head and face Skin cancer of a type other than SCC and BCC The presence of a specific underlying disease that directly leads to a disorder in wound healing, including scleroderma and morphea C44 Other and unspecified malignant neoplasm of skin Treatment - Drugs Placebo The intervention group includes oral capsule and topical solution of Sikaglocal. The patient receives one capsule daily for 2 weeks (14 capsules) and topical solution twice a day for 2 weeks (one vial of solution). The drug is prepared by Daru Darman Parshin Pod Company, whose main composition is bromelain and, along with other items, it includes vitamin C, group B vitamins including: B2, B3, B7, vitamin D, iron, zinc, copper, Centella plant extract, and sodium. Hyaluronate is combined. The medicine is stored at room temperature. In each session, the correct way to take the medicine is explained to the patient and the method of use is indicated on the product. The control group includes oral capsules and placebo topical solution. The patient receives one capsule daily for 2 weeks (14 capsules) and topical solution twice a day for 2 weeks (one vial of solution). The drug is prepared by Daru Derman Parshin Pod Company, which is an oral capsule containing starch and an oil-based topical solution. The medicine is stored at room temperature. In each session, the correct way to take the medicine is explained to the patient and the method of use is indicated on the product. Determining the effect of oral and topical cikaglocal drug on wound healing in patients after Mohs surgery, where the wound healing score is given based on the Early Healing Index (EHI). Timepoint: In each group, the number of patients will be 12, and on days 0, 7, and 14, imaging of the patients' wounds will be done, and the duration of drug use is 14 days. Method of measurement: The wound healing score is based on the Early Healing Index (EHI), which evaluates wound healing using scores from 1 to 5: a wound with very poor healing receives a score of 1, while excellent healing receives a score of 5. slow. Esfahan University of Medical Sciences Approved 2024-02-03 Ethics committee of Isfahan University of Medical Sciences Hazar Jarib Street, Isfahan University of Medical Sciences and Health Services, Central Center Isfahan Isfehan Iran (Islamic Republic of)