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IRCT20240124060790N1 IRCT 2024-02-14 Ahvaz University of Medical Sciences Effect of insulin injection,amniotic membrane and simple dressing with petroleum gauze in wound healing Comparative study of three methods of subcutaneous injection of insulin and amnion membrane and simple dressing with petroleum jelly in the repair of donor graft site in second and third degree burns in a period of one year in Taleghani Hospital of Ahvaz 2024-01-06 anticipated 120 Complete https://irct.ir/trial/75205 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study will be conducted on 120 patients and the intervention and control will be on one patient. Considering the width of the dermatome at 9 cm and the length of the skin graft at least 15 cm with relative thickness, three sections of 5 x 9 cm in the proximal, medial and distal of the wound will be randomly selected as cases and controls. Insulin, placebo (normal saline serum) will be used subcutaneously and amnion membrane as a cover in the proximal, medial and distal areas of the mentioned wound. Description of how to randomize: Using the table of random numbers, case and control groups are randomly selected between proximal wound, medial wound and distal wound. 2 2rd and 3rd degree burns. Intervention 1: Description of the intervention in the case group: NPH insulin made by Elixir factory will be injected subcutaneously in a single dose with a concentration of 1 unit per milliliter with a dose of 2 cc in 10 points. After the intervention, the wounds of the dressing patients become clear. . In addition, blood sugar measurement will be done in order to prevent side effects such as hypoglycemia in patients before and after surgery. Intervention 2: Control group:( Description of the intervention of the control group): The placebo in this study is normal saline serum, which will be injected subdermally in 10 points with a volume of 2 cc as a single dose like insulin. After the intervention, the wounds of the dressing patients become clear. On the 7th, 14th, and 21st days after the operation, the wound will be examined and a picture of the position will be taken. Intervention 3: Intervention group: In the other intervention group, the amniotic membrane is used as a wound cover. On the 7th, 14th, and 21st days after the operation, the wound will be examined and a picture of the position 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 Until final conclusions can not be spoken about the data dissemination
public Ali alizadeh
Taleghani burn hospital, Hejrat blvd., Padadshahr 2 phase
Ahvaz Iran (Islamic Republic of) 6187954386 +98 61 3554 7992 alizadeh.ali@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mahtab farhadi
Taleghani burn hospital, Hejrat blvd., Padadshahr 2 phase
Ahvaz Iran (Islamic Republic of) 6187954386 +98 61 3554 7992 alizadeh.ali@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients between 18 to 65, Patients with second and third degree burn 18 years 65 years Both Pregnant women Patients with underlying diseases such as Diabetes, chronic kidney disease، chronic liver disease, peripheral vascular disease, cardiovascular disease, collagen vascular disease, chronic skin disease ranging from autoimmune diseases to skin malignancies Heavy smokers Immunosuppressive medication users T20. 20XA- T20. 20XA:Burn of second degree of head, face, and neck, unspecified site, initial encounter.   T21. 30XA :Burn of third degree of trunk, unspecified site, initial encounter. T86.822 :for skin graft (allograft)(autograft) Treatment - Surgery Treatment - Surgery Treatment - Surgery Description of the intervention in the case group: NPH insulin made by Elixir factory will be injected subcutaneously in a single dose with a concentration of 1 unit per milliliter with a dose of 2 cc in 10 points. After the intervention, the wounds of the dressing patients become clear. . In addition, blood sugar measurement will be done in order to prevent side effects such as hypoglycemia in patients before and after surgery Control group:( Description of the intervention of the control group): The placebo in this study is normal saline serum, which will be injected subdermally in 10 points with a volume of 2 cc as a single dose like insulin. After the intervention, the wounds of the dressing patients become clear. On the 7th, 14th, and 21st days after the operation, the wound will be examined and a picture of the position will be taken Intervention group: In the other intervention group, the amniotic membrane is used as a wound cover. On the 7th, 14th, and 21st days after the operation, the wound will be examined and a picture of the position will be taken. The area of ​​the epithelialized area to follow the condition of the wound. Timepoint: مقاطع زمانی اندازه‌گیری :روز 7، 14 و 21 پس از انجام مطالعه. Method of measurement: Examining the area of ​​the epithelialized area using ImageJ software. Ahvaz University of Medical Sciences Approved 2024-01-06 Ethics committee Ahvaz Jondishapur University of Medical Sciences Taleghani Burn hospital, Hejrat blvd., Padadshar 2 phase Ahvaz Khouzestan Iran (Islamic Republic of)