]>
IRCT20210918052511N3 IRCT 2022-11-23 Mashhad University of Medical Sciences Assessment of the efficacy of topical gel containing insulin and silver nanoparticles in the treatment of second-degree burn wounds Comparison of the efficacy of using topical gel containing insulin and silver nanoparticles and topical gel containing silver nanoparticles on the duration of complete wound healing in patients with second-level burn wounds: a double-blind and randomized clinical trial 2022-11-21 anticipated 56 Complete https://irct.ir/trial/66863 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each of the 56 patients would be assigned a number between 1 and 86 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 the 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 receive the dressing based on how the allocation occurred, and they are unaware of the type of dressing received. Also, to ensure blinding, the packaging and appearance of the final gel are identical, and the packages do not design labels except for the group code. Infectious specialist and surgical and burn specialist perform all procedures on all patients. The patient, the infectious disease specialist and the subspecialist of plastic and burn surgery and the outcome assessor are blinded to the treatment groups. 3 Burn patients. Intervention 1: Intervention group: The topical gel containing insulin and silver nanoparticles is used for two weeks and this dressing in the treatment of burn wounds accelerates wound healing, reduces the need to change dressings, shortens the duration of hospitalization, reduces scar formation, temperature control, proper air permeability to the wound and reduce pain and earlier removal of the dressing. For wound dressing, the secondary dressing (dry gauze and bandage) is changed every 48 hours and if necessary, the topical gel is also used. The prepared gel is biocompatible, and the dosage of silver nanoparticles is considered to be 80 ppm per one percent of the burn surface based on previous studies. Intervention 2: Control group: The topical gel containing only silver nanoparticles is used for two weeks. For wound dressing, the secondary dressing (dry gauze and bandage) is changed every 48 hours and if necessary, the topical gel is also used. The prepared gel is biocompatible, and the dosage of silver nanoparticles is considered to be 80 ppm per one percent of the burn surface based on previous studies. 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: The 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 the industry. Conditions: Use as a reference Where to obtain: Dr. Maede Hasanpour - Faculty of Pharmacy - Room 251 - Phone 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-Imam Reza hospital, Daneshgah street
Mashhad Iran (Islamic Republic of) 91379-13316 +98 51 3802 2051 Yazarlouom@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Omid Yazarlou
Mashhad University of Medical Sciences, Daneshgah Street
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 2 and 60 are eligible to participate. Patients with second-degree burns diagnosed by the relevant physician Patients with burns that are less than or equal to 20% Patient with second-degree burns in upper and lower limbs and anterior trunk The wound is examined by a plastic and burn surgeon for necrosis and the depth of the burn. If the burned area is not a candidate for early surgery and can be healed without surgery and with minimal complications, the patient will be eligible to the study 2 years 60 years Both Delayed visit and the presence of obvious wound infection at the first visit by an infectious disease specialist 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 back of the trunk, face, head and perineum T20 Burn and corrosion of head, face, and neck Treatment - Drugs Treatment - Drugs Intervention group: The topical gel containing insulin and silver nanoparticles is used for two weeks and this dressing in the treatment of burn wounds accelerates wound healing, reduces the need to change dressings, shortens the duration of hospitalization, reduces scar formation, temperature control, proper air permeability to the wound and reduce pain and earlier removal of the dressing. For wound dressing, the secondary dressing (dry gauze and bandage) is changed every 48 hours and if necessary, the topical gel is also used. The prepared gel is biocompatible, and the dosage of silver nanoparticles is considered to be 80 ppm per one percent of the burn surface based on previous studies. Control group: The topical gel containing only silver nanoparticles is used for two weeks. For wound dressing, the secondary dressing (dry gauze and bandage) is changed every 48 hours and if necessary, the topical gel is also used. The prepared gel is biocompatible, and the dosage of silver nanoparticles is considered to be 80 ppm per one percent of the burn surface based on previous studies. 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 (presence or absence of granulation tissue, bleeding, pain, infection, and other wound complications or healing factors). Timepoint: Every 48 hours for 2 weeks. Method of measurement: Based on the scores of the variables and presence or absence (yes / no) and based on clinical observations of an infectious disease specialist and subspecialty of plastic surgery and burns. Mashhad University of Medical Sciences Approved 2022-11-04 Research ethics committee of school of medicine-Mashhad university of medical sciences Campus of Medical University of Mashhad, Azadi squer, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)