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IRCT20220908055916N1 IRCT 2023-01-19 Tehran University of Medical Sciences Effect of Nano Propolis in Donor Site Graft Healing Determination and Comparision the Effectiveness of Nano Propolis in Wound healing of the donor site Skin Graft in Patients 2023-01-21 anticipated 30 Complete https://irct.ir/trial/67764 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization is not done to select People because the Case and Control are done on One Person, but Randomization is done for the Type of Cream in the Wound Healing Site. The Lesions on the Patient's Body will be randomly selected based on the Block Classification of Four Numbers prepared by Excel Software, and will be placed in One of the Two relevant Groups to receive the Panemsan Type, Blinding description: In Order to blind the Patient and not know which Cream was used in which Area, the Blinding will be done in a (double-blind) way, so that the Patient will be given Two Gels in the same Tubes. It is given and asked from the Patient that It is the Supervisor Who knows which Lesion of the Patient with which Code, which Gel will be prescribed with which Code, and the Researcher and the Patient do not know about the Codes related to the Lesions and the Content of the Gels. Randomly, in One of the Two Skin Graft harvesting Sites, Treatment with Nano Propolis gel (Group A) and Placebo Treatment (base Gel without Propolis - Group B) will be used in the Other Place. Nanopropolis Gel and Placebo Gel are similar in Appearance, Weight, Color and Consistency and can only be recognized by a Special Code that was prepared by the harmaceutical Company in cooperation with Sharif University and with the Formulation that is available in the Attachment, and the Researcher and the Patient They do not know about the Codes related to the Content of the Gels. The Random Selection Sequence of Groups A and B will be calculated by a Statistician and Methodology Expert and maintained by a Person Who has no Other Interest or Participation in the Project. The Researchers and Subjects and the Statistical Analyst will be blind to the Content of the Gels throughout the Study and during the statistical Analysis. 3 patients need skin graft. Intervention 1: patients with skin defects candidated healing with partial thicknes skin grafts after harvesting the grafted skin at the donor site, which are divided into two equal parts with a distance, and each of these parts are selected as intervention and control subjects: intervention group: in the part that is randomly assigned to The place of intervention is selected, honey nano propolis ointment is prescribed, and after training, daily dressing is done, and on days 1-3-7-14-21-28, the condition of wound healing is checked using Bates-Jensen criteria. Intervention 2: Control group: Control group: Vaseline ointment is prescribed in the part that is randomly selected as the control area, and after training, dressing is done daily and on days 1-3-7-14-21-28 using criteria bates-jensen tests and wound healing status are examined. Yes - There is a plan to make this available What will be shared: All data will be released after de-identification When: the access period starts 6 months after the results are published To whom: all researchers Conditions: By mentioning the source, it is possible to analyze the data Where to obtain: Request from the responsible author How to obtain: Upon request, the data will be sent by e-mail within one month Comments:
public Hamed Shahdadi
Tehran,Keshavarz blvd, Imam Hospital,Plastic department
Tehran Iran (Islamic Republic of) 1444863841 +98 21 6119 2472 hamedshahdadi@yahoo.com Tehran University of Medical Sciences scientific Hamed Shahdadi
Tehran,Keshavarz blvd,Imam Hospital, Plastic department
Tehran Iran (Islamic Republic of) 1444863841 +98 21 6119 2472 hamedshahdadi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients Schaduled for partial Thickness Skin Graft with informed Consent 18 years 60 years Both history of graft harvest from donor site history of kelloid and HTS Cigarette smoking allergy history to honey history of wound healing impairment disorder old age patient(>60 years old) immune deficient patient pregnant patient with out informed consent t14.0 Superficial injury of unspecified body region Treatment - Drugs Treatment - Drugs patients with skin defects candidated healing with partial thicknes skin grafts after harvesting the grafted skin at the donor site, which are divided into two equal parts with a distance, and each of these parts are selected as intervention and control subjects: intervention group: in the part that is randomly assigned to The place of intervention is selected, honey nano propolis ointment is prescribed, and after training, daily dressing is done, and on days 1-3-7-14-21-28, the condition of wound healing is checked using Bates-Jensen criteria. Control group: Control group: Vaseline ointment is prescribed in the part that is randomly selected as the control area, and after training, dressing is done daily and on days 1-3-7-14-21-28 using criteria bates-jensen tests and wound healing status are examined. Wound healing according to bates-jensen criteria. Timepoint: 1-3-7-14-21-28 day. Method of measurement: bates-jensen scoring. Wound infection rate. Timepoint: 1-3-7-14-21-28 day. Method of measurement: examination or culture. Pain. Timepoint: 1-3-7-14-21-28 day. Method of measurement: visual analogue score. Scar. Timepoint: 1-3-7-14-21-28 day. Method of measurement: physical exam. Tehran University of Medical Sciences Approved 2022-12-24 Ethics committee of Imam Khomeini Hospital Tehran University of Medical Sciences tehran, keshavarz blvd,imam khumeini hospital تهران Tehran Iran (Islamic Republic of)