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IRCT20160118026096N3 IRCT 2021-08-22 Tehran University of Medical Sciences The effect of Topical Ointment on the Process of Wound Healing Clinical Evaluation of Topical Nanocomplex ointment on Chronic venous ulcers: A double-blind randomized clinical trial 2021-03-10 anticipated 60 Complete https://irct.ir/trial/53199 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the permuted block randomization will be used with quadruple blocks. Blocks will be generated using Excel software. In order to apply concealment in the randomization process, sealed envelopes will be used, and, Blinding description: Ointments will be given in the unbranded and untitled medical cans that patient and therapist be blind. 3 Wound Healing. Intervention 1: Intervention group: The intervention group in this study is a randomly selected 30-person group that uses an alternative medicine to improve the wound healing process. Surgery by a general surgeon After cessation of bleeding in the control group, patients' wounds are washed with normal saline solution. Apply some ointment on the wound and bandage it .(10 mg - Nanocomplex ointment - Dineh Company)Ointments are used once a day until the 14th day. Intervention 2: Control group: The control group is a randomly selected 30-person group that uses conventional treatment Vaseline. In the intervention group, after rinsing with normal saline, the patient's wound is covered with ointment and bandaged.(10 mg - Vaseline - Kimidaro Company)Ointments are used once a day until the 14th day . Yes - There is a plan to make this available What will be shared: Patient recovery results When: En 6 months after printing To whom: En Academic researchers Conditions: Only recovery results are reported Where to obtain: Dr. Nasrin Takzaree How to obtain: takzaree@tums.ac.ir Comments:
public Nasrin Takzaree
School of Medicine, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 3008 takzaree@tums.ac.ir Tehran University of Medical Sciences scientific Nasrin Takzaree
No.10 ,Porsina Ave.Tehran University of Medical Sciences,School of Medicine
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 3008 takzaree@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age range 30 to 60 years Have referred for the treatment of chronic venous ulcers. The lesion is clinically benign.6. 30 years 60 years Both The lesion is clinically malignant. The ability to create keloids or scars due to injuries Previous or current history of scroderma History of radiotherapy treatment Immunosuppressive use or defective immune system Pregnancy or breastfeeding Patient dissatisfaction with continued use of ointment Treatment - Drugs Treatment - Drugs Intervention group: The intervention group in this study is a randomly selected 30-person group that uses an alternative medicine to improve the wound healing process. Surgery by a general surgeon After cessation of bleeding in the control group, patients' wounds are washed with normal saline solution. Apply some ointment on the wound and bandage it .(10 mg - Nanocomplex ointment - Dineh Company)Ointments are used once a day until the 14th day Control group: The control group is a randomly selected 30-person group that uses conventional treatment Vaseline. In the intervention group, after rinsing with normal saline, the patient's wound is covered with ointment and bandaged.(10 mg - Vaseline - Kimidaro Company)Ointments are used once a day until the 14th day . En Wound Surface. Timepoint: Day one (surgery day), Day 4, 7 and 14 after surgery. Method of measurement: Wound healing is evaluated by measuring the wound surface, the percentage of wound healing, and the length of time needed for closure and complete repair of the wound. The surface of the wound is measured on days 1, 4, 7 and 14 after the surgery with Ferguson and Logan method. This is accomplished by placing the transparent paper on the wound and draw the wound shape. Then the transparent paper is transferred to the millimeter lattice paper and counted. Wound resizing. Timepoint: The wound surface is digitally photographed on days 1, 7 and 14 after surgery. Method of measurement: The wound surface is digitally photographed on days 1, 7 and 14 after surgery.The wound surface is then measured with Image J software. Inflammation rate. Timepoint: On days 1, 7 and 14, the amount of inflammation is determined by the doctor. Method of measurement: Determination of inflammation by a doctor 0-3 score(none- mild- moderate- severe). Determining the amount of pain. Timepoint: On days 1, 7 and 14, the patient is asked about the amount of pain by the doctor. Method of measurement: Based on patient questions and classification 0-10 score *(no pain 0 / mild pain 1-3/ moderate pain 4-6 / severe pain 7-9 / worst pain 10). Tehran University of Medical Sciences Approved 2021-03-09 Ethics committee of Tehran University of Medical Sciences Room 60., Sixth Floor., Tehran University of Medical Sciences., Qods St., Tehran Tehran Tehran Iran (Islamic Republic of) Approved 2021-03-09 Ethics committee of Tehran University of Medical Sciences Room 60., Sixth Floor., Tehran University of Medical Sciences., Qods St., Tehran Tehran Tehran Iran (Islamic Republic of)