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IRCT20191228045924N6 IRCT 2023-11-12 Mashhad University of Medical Sciences Effect of PRP-Fibrin glue and Repairing gel in treatment of second-degree burn wounds Treatment of second-degree burn wound with PRP-Fibrin glue and repairing gel 2023-12-22 anticipated 40 Complete https://irct.ir/trial/73514 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment. 2-3 Burn of second degree. Intervention 1: First intervention group: For 10 patients with second-degree burns, platelet-fibrin glue in the form of gel will be placed on the patient's wound. The number of times of use: use of fibrin gel is every 48 hours for 8 weeks, and this gel is used on the wound at the time of changing the dressing after irrigation of the wound. Fibrin glue is prepared in the clean room of the skin bank of Imam Reza Hospital. Fibrin glue is prepared in the clean room of the skin bank of Imam Reza Hospital from platelet and cryo samples taken from blood transfusion organization by project researchers and is not commercial. Intervention 2: Second intervention group: 10 patients with second-degree burns, the classical treatment for the wound will be performed, and the repairing gel with approved wound healing components in the form of gel will be used. The repairing gel will be manufactured by Omid Rajabi Pharmaceutical Factory, and the dosage of the components used is FDA-approved. The components are vitamin A (0.2 percent) - vitamin C (2 percent) - vitamin B3 (0.5 percent) - glycine amino acid. (0.5 percent) - ethanol (2 percent) - collagen (1 percent) - citric acid (2 percent) - glycerin (0.5 percent) - malic acid (1 percent) - urea (35 percent) - carboxymethyl cellulose (2 percent) - Sodium alginate (1 percent) - Benzoic acid (0.002 percent) - Propylene glycol (0.5 percent) - Methylene blue (0.1 percent) - Violet Dujancin (0.1%) - dimethyl sulfoxide (0.1%). The number of times of use: use of repairing gel is every 48 hours for 8 weeks, and these gels are used on the wound at the time of changing the dressing after irrigation of the wound. Intervention 3: Third intervention group: 10 patients with second-degree burns, in addition to the classical treatment, the repairing gel with approved wound healing components and platelet-fibrin glue will be placed on the wound. The repairing gel will be manufactured by Omid Rajabi Pharmaceutical Factory, and the dosage of the components used is FDA-approved. The components are vitamin A (0.2 percent) - vitamin C (2 percent) - vitamin B3 (0.5 percent) - glycine amino acid. (0.5 percent) - ethanol (2 percent) - collagen (1 percent) - citric acid (2 percent) - glycerin (0.5 percent) - malic acid (1 percent) - urea (35 percent) - carboxymethyl cellulose (2 percent) - Sodium alginate (1 percent) - Benzoic acid (0.002 percent) - Propylene glycol (0.5 percent) - Methylene blue (0.1 percent) - Violet Dujancin (0.1%) - dimethyl sulfoxide (0.1%). Fibrin glue is prepared in the clean room of skin bank of Imam Reza Hospital. The number of times of use: use of repairing gel and fibrin gel is every 48 hours for 8 weeks, and these gels are used on the wound at the time of changing the dressing after irrigation of the wound. Intervention 4: Control group: 10 patients with second-degree burns, only the classical wound irrigation will be continued. The number of times of use: Every 48 hours for 8 weeks, the dressing is changed on the wound. 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 is no further information
public Seyed Hasan Tavousi
Daneshgah Street, Surgical Oncology Research Center, Mashhad University of Medical Sciences, General Surgery Department, Building No. 2, Imam Reza hospital
Mashhad Iran (Islamic Republic of) 9133913716 +98 915 511 8717 TavoosiH@mums.ac.ir Mashhad University of Medical Sciences scientific Daryoush Hamidi Alamdari
Iman Reza Hospital, Daneshgah Ave
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3882 8574 hamidiad@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Confirmation of second-degree burns Having a body mass index of 18-35 No smoking, alcohol and drug addiction Not taking drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents Not having concurrent diseases that may cause problems in wound healing, such as cancers, vasculitis, kidney, liver, and heart failures Informed consent of patients no limit no limit Both The presence of a wound with an active infection requiring intravenous antibiotics or gangrene requiring amputation Failure to refer the patient to the mentioned center for follow-up and dressing change on more than two occasions T30.2 Burn of second degree, body region unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group: For 10 patients with second-degree burns, platelet-fibrin glue in the form of gel will be placed on the patient's wound. The number of times of use: use of fibrin gel is every 48 hours for 8 weeks, and this gel is used on the wound at the time of changing the dressing after irrigation of the wound. Fibrin glue is prepared in the clean room of the skin bank of Imam Reza Hospital. Fibrin glue is prepared in the clean room of the skin bank of Imam Reza Hospital from platelet and cryo samples taken from blood transfusion organization by project researchers and is not commercial. Second intervention group: 10 patients with second-degree burns, the classical treatment for the wound will be performed, and the repairing gel with approved wound healing components in the form of gel will be used. The repairing gel will be manufactured by Omid Rajabi Pharmaceutical Factory, and the dosage of the components used is FDA-approved. The components are vitamin A (0.2 percent) - vitamin C (2 percent) - vitamin B3 (0.5 percent) - glycine amino acid. (0.5 percent) - ethanol (2 percent) - collagen (1 percent) - citric acid (2 percent) - glycerin (0.5 percent) - malic acid (1 percent) - urea (35 percent) - carboxymethyl cellulose (2 percent) - Sodium alginate (1 percent) - Benzoic acid (0.002 percent) - Propylene glycol (0.5 percent) - Methylene blue (0.1 percent) - Violet Dujancin (0.1%) - dimethyl sulfoxide (0.1%). The number of times of use: use of repairing gel is every 48 hours for 8 weeks, and these gels are used on the wound at the time of changing the dressing after irrigation of the wound. Third intervention group: 10 patients with second-degree burns, in addition to the classical treatment, the repairing gel with approved wound healing components and platelet-fibrin glue will be placed on the wound. The repairing gel will be manufactured by Omid Rajabi Pharmaceutical Factory, and the dosage of the components used is FDA-approved. The components are vitamin A (0.2 percent) - vitamin C (2 percent) - vitamin B3 (0.5 percent) - glycine amino acid. (0.5 percent) - ethanol (2 percent) - collagen (1 percent) - citric acid (2 percent) - glycerin (0.5 percent) - malic acid (1 percent) - urea (35 percent) - carboxymethyl cellulose (2 percent) - Sodium alginate (1 percent) - Benzoic acid (0.002 percent) - Propylene glycol (0.5 percent) - Methylene blue (0.1 percent) - Violet Dujancin (0.1%) - dimethyl sulfoxide (0.1%). Fibrin glue is prepared in the clean room of skin bank of Imam Reza Hospital. The number of times of use: use of repairing gel and fibrin gel is every 48 hours for 8 weeks, and these gels are used on the wound at the time of changing the dressing after irrigation of the wound. Control group: 10 patients with second-degree burns, only the classical wound irrigation will be continued. The number of times of use: Every 48 hours for 8 weeks, the dressing is changed on the wound. Change from Baseline Wound Size (length and width) will be assessed in digital images taken of the wound. Timepoint: At the beginning of the study (0 days) and at the end of the eighth week of the intervention (8 weeks). Method of measurement: digital images and ruler. Visual Analog Scale changes for pain assessment. Timepoint: Every 48 hours for 8 weeks. Method of measurement: Pain will be evaluated by the visual analog scale system (VAS). The score is determined by measuring the distance (mm) between the no-pain anchor and the point that the patient marks, providing a range of scores from 0 - 10. A higher score indicates greater pain intensity. The duration of recovery is the number of days it will take for the wound to heal. Timepoint: The interval from the beginning of the study (0 days) to wound healing. Method of measurement: Counting days. Mashhad University of Medical Sciences Approved 2023-09-09 Research Ethics committees of Mashhad University of Medical Sciences Daneshgah street, the central organization of University, Quraishi construction Mashhad Razavi Khorasan Iran (Islamic Republic of)