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IRCT20240727062554N1 IRCT 2024-08-17 Bagheiat-allah University of Medical Sciences Effect of Topical Royal on the Improvement of Bedsores Investigating the Effect of Topical Royal Jelly on the Improvement of Bedsores in Hospitalized Patients in ICU 2024-08-31 anticipated 60 Complete https://irct.ir/trial/78215 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: -Randomization Method: Minimization Minimization is recognized as a valid approach for randomization, particularly in clinical trials where we want to ensure balance between treatment groups based on certain overlapping variables (such as age, gender, and severity of pressure ulcers). -Unit of Randomization: The unit of randomization in this study is a patient in the ICU who has developed a pressure ulcer. Each patient will be assigned to one of the treatment groups (receiving royal jelly) or the control group (receiving a placebo or standard care). -Randomization Tools: Statistical software in Python will be used. -Constructing the Randomization Sequence: The minimization method ensures that treatment groups are balanced concerning predetermined overlapping variables. Here’s how to construct the randomization sequence: 1. Identify Overlapping Variables: Select the variables that are important for balance, such as age, gender, severity of pressure ulcers, or comorbid conditions. 2. Initiate Randomization: Start with the first patient and randomly assign them to one of the groups (treatment or control). 3. Minimization Algorithm: - For each subsequent patient, calculate the imbalance for both treatment groups based on the overlapping variables. - Assign the new patient to the treatment group that minimizes the overall imbalance across the overlapping variables. - This process can be repeated for each patient enrolled in the study. -Allocation Concealment: We will use Centralized Randomization: A third party will manage the randomization and allocation process. This person will not be involved in patient care or data collection, Blinding description: In this study, blinding was done only for the patients. This means that only the patients do not know what group they are in. During wound dressing, all patients or their companions will be told that the same dressings will be used for them. The wound specialists and the people responsible for the study will know which type of treatment the patient will receive. N/A Pressure ulcer(Bed sore). Intervention 1: Intervention group: To 30 patients with bed sores in the ICU who were enrolled in the study by a wound expert, two days a week for 8 weeks, in addition to the routine treatment of bed sores (Tabasept spray, X-Plates gel, Urocel 10x10 and Tabaflex 10x10), the combination of royal jelly and honey will be given, and the patients will be followed up by the PUSH questionnaire during this period. Intervention 2: Control group: To 30 patients with bedsores in the ICU who were included in the study by a wound expert, two days a week for 8 weeks, routine treatment of bedsores (Tabasept spray, X-Plates gel, Eurocell 10x10 and Tabaflex 10x10) will be given and patients will be followed up by PUSH questionnaire during this period. Yes - There is a plan to make this available What will be shared: Non-identifiable personal information of participants in this study will be shared. Also, the protocol, results and statistical analysis of this study will be published in the relevant articles. When: The non-identifiable personal information of the participants will be available after the publication of the relevant articles. To whom: The non-identifiable personal information of the participants will be made available to other researchers at the scientific institutions after the investigation by the research team. Conditions: Non-identifiable personal information of participants can only be used for research purposes. Where to obtain: Non-identifiable personal information of the participants can be obtained by sending an email to Dr. Reza Ghanbarpoor (ghanbarpoor@bmsu.ac.ir) or Dr. Mirerfan Aribi (mirerfan.aribi@gmail.com). How to obtain: Other researchers in scientific institutions can send their request to Dr. Reza Qanbarpour or Dr. Mirerfan Eribi. After consultation and approval of the research team, the results will be sent to them. Comments:
public Mir Erfan Aribi
Baqiyatallah Hospital, Mollasadra Ave., Vanak Square
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8805 0435 mirerfan.aribi@gmail.com Bagheiat-allah University of Medical Sciences scientific Reza Ghanbarpoor Dizbon
Baqiyatallah Hospital, Mollasadra Ave., Vanak Square
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8805 0435 ghanbarpoor@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) All patients hospitalized in ICU whose bedsores are studied by a wound expert. 18 years no limit Both Patients who have gangrene. Patients who have osteomyelitis. Patients who have severe sepsis. Patients who have heavy smoking or alcohol consumption. Patients who have liver failure. Patients who have diabetes. Taking drugs that may interfere with the wound healing process (glucocorticoid, immunosuppressive and cytotoxic drugs). Proper follow-up is not done by the patient. The patient does not consent to continue the follow-up. Failure to respond to treatment (wounds that do not respond to treatment after two months are included in this group). The age of the patient is under 18 years. L89 Pressure ulcer Treatment - Other Treatment - Other Intervention group: To 30 patients with bed sores in the ICU who were enrolled in the study by a wound expert, two days a week for 8 weeks, in addition to the routine treatment of bed sores (Tabasept spray, X-Plates gel, Urocel 10x10 and Tabaflex 10x10), the combination of royal jelly and honey will be given, and the patients will be followed up by the PUSH questionnaire during this period. Control group: To 30 patients with bedsores in the ICU who were included in the study by a wound expert, two days a week for 8 weeks, routine treatment of bedsores (Tabasept spray, X-Plates gel, Eurocell 10x10 and Tabaflex 10x10) will be given and patients will be followed up by PUSH questionnaire during this period. Bed sore healing time. Timepoint: Twice a week for 8 weeks. Method of measurement: The amount of time it takes for the PUSH score to reach zero or one. The length of the bed sore. Timepoint: Twice a week for 8 weeks. Method of measurement: Using a sterile ruler. The width of the bed sore. Timepoint: Twice a week for 8 weeks. Method of measurement: Using a sterile ruler. Bed sore secretions. Timepoint: Twice a week for 8 weeks. Method of measurement: It is classified based on the opinion of the expert and PUSH criteria. Type of bed sore. Timepoint: Twice a week for 8 weeks. Method of measurement: Based on the expert's observation and opinion, the type of bed sore is classified. Bagheiat-allah University of Medical Sciences Approved 2024-06-29 Research Ethics Committees of Baqiyatallah Hospital Baqiyatallah Hospital, Mollasadra Ave., Vanak Square Tehran Tehran Iran (Islamic Republic of)