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IRCT20090515001906N13 IRCT 2023-12-02 Kermanshah University of Medical Sciences Use of actinidin in skin grafting Investigating the efficacy of actinidin isolated epidermis grafting in repigmentation of vitiligo patients 2022-09-23 anticipated 96 Complete https://irct.ir/trial/73762 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Central randomization: In this method, a random sequence is provided to a specific center, and the researcher is contacted based on the order in which the research participants (patients) entered the research area (Haj Dayi Clinic) and the participant is randomly assigned to one of the two special groups. Among the methods of communication, we can refer to telephone, face-to-face, etc., in this research, the face-to-face method is used. N/A Vitiligo. Intervention 1: Intervention group: For each patient, after local anesthesia in the donor site, the epidermis is separated with a thin layer of dermis by a dermatome. In the next step, the separated skin is placed in actinidin enzyme with a volume of 5 mg per liter and a volume of 2 ml and placed in an incubator at a temperature of 37 degrees for 10 minutes. Epidermis separated by actinidin is placed in contact with the dermis of the receiving area and nano-dressed. Intervention 2: intervention group: for each patient, a suction-blister device is placed for one to two hours to separate the epidermis in the donor site, and then the separated epidermis is transplanted to the recipient site, whose epidermis has already been removed with a laser device. Yes - There is a plan to make this available What will be shared: The main outcomes of the study will be shared When: 2 months To whom: If requested, results will be made available to other academic researchers Conditions: Collected data is confidential and will not be shared with anyone else Where to obtain: To receive the documentation, email send for update manager How to obtain: In a 15-day period, the documents will be sent e-mail Comments:
public Marzieh Fathi
Golestan, Gol e Sorkh Blvd, Haj Dayi Clinic
Kermanshah Iran (Islamic Republic of) 6717735838 +98 83 3835 9054 rasad313313@gmail.com Kermanshah University of Medical Sciences scientific Ali Ebrahimi
Golestan, Gol e Sorkh Blvd, Haj Dayi Clinic
Kermanshah Iran (Islamic Republic of) 6717735838 +98 83 3835 9054 aebrahimi@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Age 13 to 60 years The presence of at least two affected areas Persistent vitiligo vulgaris or segmental vitiligo (there has been no increase in the size of depigmented patches for at least one year) Lack of appropriate response to drug and phototherapy treatments The rate of involvement is less than 30% of the total body surface 13 years no limit Both Appropriate response to drug and phototherapy treatments History of cardiovascular disease Age under 13 years and over 60 years Pregnancy and breastfeeding Positive history of Kobner Phenomenon Presence of hypertrophic or keloid scars Unstable vitiligo during the past 1 year Presence of active infection at the site L80 Vitiligo Treatment - Surgery Treatment - Surgery Intervention group: For each patient, after local anesthesia in the donor site, the epidermis is separated with a thin layer of dermis by a dermatome. In the next step, the separated skin is placed in actinidin enzyme with a volume of 5 mg per liter and a volume of 2 ml and placed in an incubator at a temperature of 37 degrees for 10 minutes. Epidermis separated by actinidin is placed in contact with the dermis of the receiving area and nano-dressed. intervention group: for each patient, a suction-blister device is placed for one to two hours to separate the epidermis in the donor site, and then the separated epidermis is transplanted to the recipient site, whose epidermis has already been removed with a laser device. The degree of repigmentation is described as poor, moderate, good and excellent. Timepoint: The beginning of the study, the second week, the second month and the sixth month. Method of measurement: Taking photos with Finepix camera and comparing photos at set times. Kermanshah University of Medical Sciences Approved 2023-05-28 Research Ethics Committee of Kermanshah Medical School No. 1 , Medical School., Parastar Blvd Kermanshah Kermanshah Iran (Islamic Republic of)