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IRCT20230408057844N1 IRCT 2023-04-12 Kerman University of Medical Sciences The effect silver nanoparticles in the healing of skin wounds Evaluation of the effect of alginate gel containing silver nanoparticles in the healing of skin wounds - Phase 1 and 2 clinical trial 2023-04-08 anticipated 30 Complete https://irct.ir/trial/69466 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: Random allocation of patients to the intervention and control groups is done by the block diagnosis method and using blocks of 4, in each of the blocks 2 people are placed in the intervention group and 2 people in the control group, but they must be regularly to be placed It will be a random form that this will be done with Winpappy software, Blinding description: In this study, the researcher numbers the formulation of the container containing the medicinal formula so that the patient is unaware of the contents of the container. 1-2 wound healing. Intervention 1: Intervention group: In this group, after washing the wound with normal saline, patients put silver gel on the site and put a protective dressing on it. Intervention 2: Control group: In this group, after washing the wound with normal saline, common wound treatment that includes silver sulfadiazine and nitrofurazone ointment is applied to the wound every other day. Yes - There is a plan to make this available What will be shared: Non-identifiable personal data of the participants, study protocol, statistical analysis map, informed consent form will be shared after the end of the study. When: 6 months after the results are published To whom: All researchers working in academic and scientific institutions Conditions: The data can be analyzed and exploited within the framework of the study protocol, but the right to publish the data will be with the research team. People who wish to have access to data or documents should send their written request to the project manager's email and explain their reason for needing these data and documents and how they will use them. Where to obtain: Corresponding of project How to obtain: The applicant must first submit a request including the requested data or document, the reason for the need for this data or document and the uses he will make of it along with a brief introduction of himself and the company or university where he works. This request will be reviewed as soon as possible, and then, taking into account the conditions of the request, if the answer is positive, the data will be provided to the applicant. Comments:
public Mohamad Javad Mirzaei-Parsa
Stem Cell Innovation Center and Regenerative Medicine, Shefa Crossroads, Kerman
Kerman Iran (Islamic Republic of) 7618747653 +98 34 3121 5682 mj.mirzaei@kmu.ac.ir Kerman University of Medical Sciences scientific Mohamad Javad Mirzaei-Parsa
Stem Cell Innovation Center and Regenerative Medicine, Shefa Crossroads, Kerman
Kerman Iran (Islamic Republic of) 7618747653 +98 34 3121 5682 mj.mirzaei@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Conditions for entering the study: age between 18 and 95 years old, having grade 2 wounds, no history of antibiotic use, conditions for leaving the study: patients who do not want to continue the clinical trial for any reason. Patients with underlying diseases such as uncontrolled diabetes, autoimmune diseases, or patients undergoing chemotherapy drugs, etc. Wound infection. In these cases, the patient will be removed from the research units and the treatment method will be changed according to the doctor's opinion. 18 years 95 years Both Treatment - Drugs Treatment - Drugs Intervention group: In this group, after washing the wound with normal saline, patients put silver gel on the site and put a protective dressing on it. Control group: In this group, after washing the wound with normal saline, common wound treatment that includes silver sulfadiazine and nitrofurazone ointment is applied to the wound every other day. Degree of wound, presence or absence of infection. Timepoint: Days zero, 3, 7 and 10. Method of measurement: Examining the size of the wound and using a ruler and ImageJ software, examining microbial cultures. Kerman University of Medical Sciences Approved 2022-04-16 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)