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IRCT20210918052511N1 IRCT 2021-09-24 Mashhad University of Medical Sciences Assessment of the efficacy of amnion dressing in wound healing of skin graft donor sites Assessment of the efficacy of amnion dressing in wound healing of skin graft donor sites (superficial second-degree wound) in the lateral thigh and its comparison with conventional wound dressing 2021-10-22 anticipated 58 Complete https://irct.ir/trial/58813 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each of the 58 patients would be assigned a number between 1 and 58 which is randomized by using random.org/integers in two columns. ​The numbers of the first column are assigned to group A and the second column is assigned to group B. With a lottery method, each column (A or B) is assigned to intervention or control groups, Blinding description: Prior to participating in the trial, all patients or their legal representatives sign an informed consent form and are informed that they will be in one of two treatment groups. After that, participants enter the operating room and receive the dressing based on how the allocation occurred, and they are unaware of the type of dressing received. N/A Burn patients. Intervention 1: Intervention group: The amnion dressing is used for two weeks and this dressing is provided by Sinacell Co.Amnion membrane as a biological dressing in the treatment of burn wounds accelerates wound healing, reduces the need to change dressings, shorten the duration of hospitalization, reduce scar formation, temperature control, proper air permeability to the wound and reduce pain and earlier removal of the dressing . It is used once for dressing the donor site in the operating room and the secondary dressing (dry gauze and bandage) is changed every 48 hours. Intervention 2: Control group: includes the conventional treatment (a layer of fatty gauze, dry gauze and then bandaging) for two weeks. Yes - There is a plan to make this available What will be shared: Part of the data is related to the main outcome and the secondary outcome can be shared. When: Access period starts 3 months after the results are published To whom: The data is available to researchers working in academic and scientific institutions as well as people working in industry. Conditions: Use as a reference Where to obtain: Dr. Maede Hasanpour - Faculty of Pharmacy - Room 233 - Phon number 09113145617-maede.hasanpour@yahoo.com How to obtain: After making a call via email or phone, the desired data will be sent using email or post. Comments:
public Dr Omid Yazarlou
Burn Department of Imam Reza Hospital
Mashhad Iran (Islamic Republic of) 91379-13316 +98 51 3802 2051 Yazarlouom@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Omid Yazarlou
Burn Department of Imam Reza Hospital
Mashhad Iran (Islamic Republic of) 91379-13316 +98 51 3802 2051 Yazarlouom@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients between the ages of 15 and 55 are eligible to participate. Have a severe burn of grade 2 or higher that requires a skin graft Patients with burns that are less than or equal to 20% Patient with deep second degree burns in upper and lower limbs and anterior trunk except lateral thigh 15 years 55 years Both Patients who are receiving chemotherapy Patients taking corticosteroids or cytotoxic medicines Pregnancy Cancer, cytotoxic drugs, immunosuppressants, and the presence of chronic diseases other than diabetes that affect wound healing, such as severe vascular disease, lupus, rheumatoid arthritis, and renal failure Smoking The presence of an underlying disease leads to a defective immune system Diabetic patients Taking drugs that lead to a defective immune system. Burns in the lateral thigh area. T20 Burn and corrosion of head, face, and neck Treatment - Devices Treatment - Devices Intervention group: The amnion dressing is used for two weeks and this dressing is provided by Sinacell Co.Amnion membrane as a biological dressing in the treatment of burn wounds accelerates wound healing, reduces the need to change dressings, shorten the duration of hospitalization, reduce scar formation, temperature control, proper air permeability to the wound and reduce pain and earlier removal of the dressing . It is used once for dressing the donor site in the operating room and the secondary dressing (dry gauze and bandage) is changed every 48 hours. Control group: includes the conventional treatment (a layer of fatty gauze, dry gauze and then bandaging) for two weeks. Duration of complete wound healing. Timepoint: Every 48 hours. Method of measurement: Based on the clinical observations of an infectious disease specialist and plastic and burn surgeon. Wound condition, including the presence or absence (yes/no) of granulation tissue, bleeding, pain, infection, and other wound complications or healing factors are evaluated. Timepoint: Every 48 hours. Method of measurement: Based on the scores of the variables and presence or absence (yes / no). Sina Cell Co. Approved 2021-08-15 research ethics committee of school of medicine-Mashhad university of medical sciences Azadi squer- campus of Medical University of Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)