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IRCT20191228045924N5 IRCT 2023-07-10 Mashhad University of Medical Sciences Investigating the effect of repairing gel and platelet-fibrin glue in the healing of wounds Increasing the effectiveness of platelet-fibrin glue in the healing of recalcitrant wounds by adding the repairing gel which has the approved components in wound healing 2023-07-20 anticipated 40 Complete https://irct.ir/trial/70780 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: The blocked method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization ensures that there is no significant imbalance between groups at any time during randomization, and at certain points the number of participants in each group is equal. Random number table using www.randomization.com In the random block method, 10 blocks of four of different permutations of letters ABCD are considered, and patients are divided into four groups accordingly. Randomization Type: Blocked Allocation Concealment method The sealed envelope is used as a means of randomization and concealment. The method of sealed envelopes is that the envelopes will be prepared and printed by a member of the research team and random numbers with the help of Randomaize.com and placed inside the envelope. The lid of the envelopes will be closed and its contents will not be visible from the outside. First, the purpose of the study is explained to the person who meets the stated conditions, and if the person wishes, he signs the informed consent form and takes an envelope, and then opens it based on the contents of the envelope, the person is in group 1 or 2 or 3 or 4 is entered, Blinding description: First, this study is explained to the participants it is a three-blind study and includes three intervention groups and one control group. 40 patients with chronic wounds, who did not respond to classical treatment after 3 months and the damage is still not healed, are included in the study. 10 patients in each group: Group 1 (fibrin glue) - Group 2 (repairing gel) - Group 3: (platelets-fibrin glue and repairing gel) - Group 4: (classic wound irrigation treatment). The participants will not know which group they belong to. The statistical analyzer and evaluator are not also informed about the groups. 2-3 Chronic Wound. Intervention 1: First intervention group: 10 patients with chronic wounds, the classical treatment will be performed, and then platelet-fibrin glue in the form of gel will be placed on the patient's wound. 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. Fibrin glue is prepared in the clean room of skin bank of Imam Reza Hospital. Intervention 2: Second intervention group: 10 patients with chronic wounds, 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%), which is prepared as a gel. 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 3: Third intervention group:10 patients with chronic wounds, 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%), which is prepared as a gel. 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 chronic wounds, 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 Daryoush Hamidi Alamdari
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 +98 915 101 7650 hamidiad@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) Having a single wound on the body that has been at least 3 months old and has not been repaired by wound irrigation with normal saline and changing the dressing Having a body mass index of 18-35 Sign the informed consent by patient no limit no limit Both Having concurrent diseases that may cause problems in wound healing, such as cancers, vasculitis, kidney and liver failure, and heart failure Taking certain drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents T01.9 Multiple open wounds, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group: 10 patients with chronic wounds, the classical treatment will be performed, and then platelet-fibrin glue in the form of gel will be placed on the patient's wound. 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. Fibrin glue is prepared in the clean room of skin bank of Imam Reza Hospital. Second intervention group: 10 patients with chronic wounds, 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%), which is prepared as a gel. 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. Third intervention group:10 patients with chronic wounds, 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%), which is prepared as a gel. 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 chronic wounds, 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. The amount of pain. Timepoint: It is measured after two days of changing the dressing. Method of measurement: Visual Analogue Scale. The duration of recovery, which is the number of days it takes for the wound to heal. Timepoint: Every 24 hours (every day). Method of measurement: By visual observation. Presence of inflammation and infection. Timepoint: Before the intervention and after the intervention every week for two month. Method of measurement: Clinical examination. Quality of Life. Timepoint: Before the intervention and after the intervention. Method of measurement: Completing the SF36 questionnaire. Reepithelialisation and wound closure. Timepoint: Every week for two month after dressing. Method of measurement: Clinical observation. Mashhad University of Medical Sciences Approved 2023-06-17 Research Ethics committees of Mashhad University of Medical Sciences Daneshgah street, the central organization of University, Quraishi Building Mashhad Razavi Khorasan Iran (Islamic Republic of)