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IRCT20111118008122N2 IRCT 2019-06-24 Tehran University of Medical Sciences The effect of local insulin injection on the wound healing process The effect of local insulin injection on the healing process of split-thickness skin graft donor site in comparison to the placebo 2019-06-10 anticipated 30 Complete https://irct.ir/trial/39820 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using table of random numbers, case and control groups will be chosen (proximal or distal site of the wound), Blinding description: This double-blind study will conduct in such a way that the patients and the assessing group will not know the site of drug injection and the choice of the injection site will be random. 2-3 Skin Grafting. Intervention 1: In the case group, a single dose of NPH insulin (Exir, Iran) with the concentration of 1IU/ml and the dose of 2 ccs will be injected subdermally at 12 points of the wound. After the intervention, transparent dressing will be used for covering the wound. The wound site will be explored at the 7th, 14th and 21st day of the postoperative period and some photos will be taken. in addition, measuring the blood glucose will be done in the pre and postoperative period in order to prevent insulin side effects such as hypoglycemia. Intervention 2: Control group (Normal saline): It will be injected as a single dose of 2cc in 12 points subdermally like the insulin. After the intervention, transparent dressing will be used for covering the wound. The wound site will be explored at the 7th, 14th and 21st day of the postoperative period and some photos will be taken. 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 there are no other information
public Sohrab Moradi Bajestani
Tehran Province, Tehran, District 12, Wahdat-e-Islami St.
Tehran Iran (Islamic Republic of) 1199663911 +98 912 377 0755 dr.smoradib@gmail.com Tehran University of Medical Sciences scientific Shahriar Haddady Abianeh
Tehran Province, Tehran, District 12, Wahdat-e-Islami St.
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5560 9951 h_abianeh@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) STSG donor site at least more than 10 cm length and age between 18 and 65 year-old 18 years 65 years Both Age below 18 years Age above 65 years Diabetes Malnutrition History of vascular diseases Smoking Pregnancy T86.82 Complications of skin graft (allograft) (autograft) Treatment - Drugs Treatment - Drugs In the case group, a single dose of NPH insulin (Exir, Iran) with the concentration of 1IU/ml and the dose of 2 ccs will be injected subdermally at 12 points of the wound. After the intervention, transparent dressing will be used for covering the wound. The wound site will be explored at the 7th, 14th and 21st day of the postoperative period and some photos will be taken. in addition, measuring the blood glucose will be done in the pre and postoperative period in order to prevent insulin side effects such as hypoglycemia. Control group (Normal saline): It will be injected as a single dose of 2cc in 12 points subdermally like the insulin. After the intervention, transparent dressing will be used for covering the wound. The wound site will be explored at the 7th, 14th and 21st day of the postoperative period and some photos will be taken. Evaluating epithelized area for assessing the wound site. Timepoint: َAt day 7, 14 and 21 after STSG. Method of measurement: ImageJ software. Tehran University of Medical Sciences Approved 2018-10-20 Ethical committee of Tehran University of Medical Sciences Tehran University of Medical Science, Enghelab St, Poursina Ave,Tehran, Iran Tehran Tehran Iran (Islamic Republic of)