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IRCT20240130060864N1 IRCT 2024-02-19 Kermanshah University of Medical Sciences Adhesive hydrogel for wound dressing Active adhesive hydrogel as second grade wound dressing 2024-04-18 anticipated 30 Complete https://irct.ir/trial/75243 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization method will be used using blocks of 4. A third person who is not involved in the process of diagnosing and evaluating patients will create a random sequence using the site: https://www.sealedenvelope.com and the number of blocks will be determined based on the sample size. Each patient will be given a unique code that can be created on this site. Therefore, concealment is observed and the people involved in the study do not know in which group the next person will be placed and they will not know about the random sequence; Only the statistics consultant will know about the random sequence and the codes will remain with them. 3 Second degree skin wound. Intervention 1: Control group: In this group, common commercial dressings that are dry and impregnated with silver are used. These dressings only play the role of preventing infection by silver and isolating the wound environment from the surrounding atmosphere. Intervention 2: Intervention group: In this group, the unique hydrogel of this study is used for volunteers. This dressing is placed on the wound so that it covers the wound. Then they are changed every other day for 14 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of people's information and the possibility of commercialization of the dressing, it is not possible to share data
public Dr Farjam Goudarzi
Faculty of Medicine, Razi Blvd., Kermanshah, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714869914 +98 919 521 6837 farjam.goudarzi@gmail.com Kermanshah University of Medical Sciences scientific Dr Farjam Goudarzi
Razi Blvd. Faculty of Medicine
Kermanshah Iran (Islamic Republic of) 6714869914 +98 919 521 6837 farjam.goudarzi@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Patients include men and women with second-degree skin ulcers no limit no limit Both Diabetes HIV Diseases and problems of the immune system Pregnancy Lactating or those planning to become pregnant Uncontrolled infection All types of skin allergies T14.1 Open wound of unspecified body region Treatment - Devices Treatment - Devices Control group: In this group, common commercial dressings that are dry and impregnated with silver are used. These dressings only play the role of preventing infection by silver and isolating the wound environment from the surrounding atmosphere. Intervention group: In this group, the unique hydrogel of this study is used for volunteers. This dressing is placed on the wound so that it covers the wound. Then they are changed every other day for 14 days. The rate of skin wound closure compared to the control group. Timepoint: 14 days. Method of measurement: Photographing the wound and analyzing it semi-quantitatively with ImageJ software. Skin itching. Timepoint: During the intervention. Method of measurement: Oral. Erythema. Timepoint: During the intervention. Method of measurement: Oral. Dry skin feeling. Timepoint: During the intervention. Method of measurement: Oral. Kermanshah University of Medical Sciences Approved 2024-01-16 Ethics Committee of Kermanshah Medical Sciences Beheshti BLVD Kermanshah Kermanshah Iran (Islamic Republic of)