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IRCT20250610066159N2 IRCT 2025-10-17 Pajoohesh BAMA Co. Treatment of Pressure Ulcers with Nano-Melissa (Lemon Balm) Efficacy of a Smart Nano-Wound Dressing in Pressure Ulcer Healing: A Randomized Clinical Trial 2025-11-21 anticipated 60 Recruiting https://irct.ir/trial/84495 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization sequence was generated by an independent statistician using R software. Block randomization with variable block sizes (4 and 6) was applied to prevent predictability. The allocation list was concealed using sequentially numbered, opaque, sealed envelopes (SNOSE). After baseline assessment, each participant’s envelope was opened by a nurse not involved in sequence generation, and the assigned dressing type was applied accordingly. The study was assessor-blinded; outcome assessors and the data analyst were unaware of group allocation, Blinding description: A stratified randomization method will be used. Patients will be divided into two groups (intervention and control) based on the presence of pressure ulcers, and randomization within each group will be performed using a pre-prepared randomization list. This list will be generated prior to the start of the study. The principal investigator will introduce the selected patients to the clinical caregiver and the outcome assessor (a nursing specialist), who will be responsible for the process. According to the list, wound treatment will be carried out using either the nano-smart wound dressing or the standard wound dressing. N/A Condition 1: Pressure ulcer- Pressure ulcer- Nano wound dressing. Condition 2: Pressure ulcer. Condition 3: Pressure ulcer. Intervention 1: Intervention group: Patients with pressure ulcers treated with the nano-smart wound dressing alongside standard wound care. Intervention 2: Control group: Patients with pressure ulcers treated with standard wound dressing alongside standard wound care. Yes - There is a plan to make this available What will be shared: - Results of the effectiveness of smart nanowound dressing in pressure ulcer healing: a randomized clinical trial - Results and data will be published after de-identification of individuals. When: 1 year after the end of the study To whom: Researchers and people working in the fields of medicine and medical engineering Conditions: The data will be accessible to other authorized persons upon request and permission from the project implementer. Where to obtain: The data will be accessible to the parties upon request from the project administrator. How to obtain: 1- Written request from the project manager 2- Check the applicant's qualifications 3- Approval by the manager and colleagues 4- Send approval and provide access to the applicant Comments:
public Ghazaleh Chizari Fard
Unit 9, No. 42, Maleki Street, East Golbarg, Bagheri Highway, Tehranpars.
Tehran Iran (Islamic Republic of) 1651897463 +98 21 7772 7495 chizarigh@gmail.com Pajoohesh BAMA Co. scientific Ghazaleh Chizari Fard
Unit 9, No. 42, Maleki Street, Golbarg Sharghi, Bagheri Highway, Tehranpars, Tehran, Iran
Tehran Iran (Islamic Republic of) 1651897463 +98 21 7772 7495 chizarigh@gmail.com Pajoohesh BAMA Co. Iran (Islamic Republic of) Patients with pressure ulcers (decubitus ulcers/bedsores) Participants aged between 18 and 80 years Participants who are willing and able to comply with the use of the smart wound dressing Participants who provide signed written informed consent 18 years 80 years Both Not applicable. L89.002 L89.003 L89.004 Pressure ulcer of unspecified elbow, stage 2, stage 3 and Stage IV Pressure ulcer of unspecified elbow, stage 3 Pressure ulcer of unspecified elbow, stage 4 Treatment - Devices Treatment - Devices Intervention group: Patients with pressure ulcers treated with the nano-smart wound dressing alongside standard wound care Control group: Patients with pressure ulcers treated with standard wound dressing alongside standard wound care The incidence of wound infection or recurrence of necrosis. Timepoint: Days 3, 7, and 14. Method of measurement: A visual observation–based scoring system. Intensity of pain. Timepoint: Days 3, 7, and 14. Method of measurement: Assessment by visual inspection. The extent of changes in IL-6, TNF-α, CRP. Timepoint: Days 3, 7, and 14. Method of measurement: Biochemical analysis. Pajoohesh BAMA Co. Approved 2025-05-18 Ethics committees Bam University of Medical Science Shahid Rajaei Boulevard- Sardarān-e Shahid Square- Bam- Iran Bam Kerman Iran (Islamic Republic of)