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IRCT20230116057136N1 IRCT 2023-05-30 Esfahan University of Medical Sciences The effect of topical insulin on wound healing in diabetic patients Investigating the effect of local insulin administration on wound healing in diabetic patients who underwent surgery 2023-05-22 anticipated 40 Complete https://irct.ir/trial/68346 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random sequence is prepared by biostatistics specialist and using excel software, a random table for 40 patients is provided to the researcher. The randomization is based on 4 random blocks because we have two groups of comparisons. Ten blocks of 4 that will be prepared using the sequence table. The allocation of participants is done using concealment with the method of closed envelopes. In this method, the sequence table designed in the previous section is used. Because of the type of intervention (is known), there is no possibility of blindness. 3 Laparotomy candidate patients. Intervention 1: Intervention group: Patients in the intervention group underwent subcutaneous wound injection with regular insulin at the rate of 0.2 units per kilogram of body weight diluted with 5 cc of distilled water and then using a 5 cc syringe and insulin needle subcutaneously and uniformly for 10 Feinstein cut centimeter is injected. Intervention 2: Control group: Patients in the control group will be injected with distilled water (with maximum effort to avoid pain and without any anesthetic). 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 I haven't decided yet, the release schedule is not clear yet
public Dr. Mino Movahdi
Hazar Jarib Street, Isfahan University of Medical Sciences, Faculty of Medicine
Esfahan Iran (Islamic Republic of) 81746 +98 31 3620 1274 internal@med.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Mino Movahdi
Isfahan - Azadi Square - Isfahan University
Esfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۴۱ +98 31 3793 2128 moavenat-amouzeshi@dean.ui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having diabetes Indication of laparotomy with standard Feinstein incision Receive standard prophylactic antibiotics Declaration of informed consent to participate in the study 20 years 80 years Female having an underlying disease that affects the wound healing process, such as cancer and neoplasm, immunodeficiency, history of chemotherapy and radiotherapy Re-incision in similar site of previous surgery Visceral injury during surgery Simultaneity of another surgery The need for blood transfusion during surgery Treatment - Drugs Placebo Intervention group: Patients in the intervention group underwent subcutaneous wound injection with regular insulin at the rate of 0.2 units per kilogram of body weight diluted with 5 cc of distilled water and then using a 5 cc syringe and insulin needle subcutaneously and uniformly for 10 Feinstein cut centimeter is injected. Control group: Patients in the control group will be injected with distilled water (with maximum effort to avoid pain and without any anesthetic) Infection and purulent discharge. Timepoint: One week, two weeks, four weeks after cutting. Method of measurement: Physical examination and history. Pain. Timepoint: One week, two weeks, four weeks after cutting. Method of measurement: Physical examination and history. Necrotic fascism. Timepoint: One week, two weeks, four weeks after cutting. Method of measurement: Physical examination and history. Formation of granulation tissue. Timepoint: One week, two weeks, four weeks after cutting. Method of measurement: Physical examination and history. Wound healing time. Timepoint: One week, two weeks, four weeks after cutting. Method of measurement: Physical examination and history. Cellulite. Timepoint: One week, two weeks, four weeks after cutting. Method of measurement: Physical examination and history. Bleeding. Timepoint: One week, two weeks, four weeks after cutting. Method of measurement: Physical examination and history. Wound surface. Timepoint: One week, two weeks, four weeks after cutting. Method of measurement: Physical examination and history. Fasting blood sugar test. Timepoint: Before injection and then at an interval of one hour and 4 hours after injection. Method of measurement: Using a glucometer. Readmission. Timepoint: Intervals of one week, two weeks, four weeks after cutting. Method of measurement: Patient file. Esfahan University of Medical Sciences Approved 2022-11-17 Ethical Committee of Isfahan University of Medical Sciences Motahari St., Shahid Dr. Beheshti Hospital Esfahan Isfehan Iran (Islamic Republic of)