Investigating the Effect of Topical Royal Jelly on the Improvement of Bedsores in Hospitalized Patients in ICU

Evaluation of the effect of topical royal jelly on the healing process of pressure ulcers Evaluation of the effect of the combination of royal jelly and local honey in reducing pressure ulcer secretion, reducing the area of ​​bed sores, reducing the score of the PUSH criterion, on the type of bedsores, on the healing time of bedsores.

A clinical trial with a control group and an intervention group, a single blind, randomized on 60 patients, was used for randomization using the minimization method using Python.

In order to investigate the effectiveness of royal jelly on patients hospitalized in the ICU department of Baqiyatullah Hospital, the patients' bedsores are followed for 8 weeks based on PUSH score. For single blinding, only the doctors and nurses who are responsible for the implementation of the design, will know which group received royal jelly and which only received routine treatment. Patients and other doctors will not be aware of this process.

Inclusion criteria: All patients hospitalized in the ICU, whose bedsores were examined by a wound specialist, were included in the study. Conditions of non-entry: patients with gangrene, osteomyelitis, severe sepsis, heavy smoking or alcohol consumption, liver failure, diabetes and taking drugs that may interfere with the wound healing process, lack of proper follow-up by patient, lack of consent to continue follow-up, lack of response to treatment, age under 18 years

The control group will receive the usual treatment of bedsores in the hospital, and the combination of honey and royal jelly, also will be added to the intervention group.

Investigation of bed sore healing time, bed sore length and width, bed sore secretions and bed sore type for 8 weeks according to PUSH criteria

-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.

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

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.

The non-identifiable personal information of the participants will be available after the publication of the relevant articles.

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.

Non-identifiable personal information of participants can only be used for research purposes.

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).

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.