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IRCT20230715058787N1 IRCT 2023-10-23 Mazandaran University of Medical Sciences Burn repair with Chitosan dressing Clinical trial of the Efficacy of Chitosan Hydrogel Wound dressing Loaded with two Antibiotics with Synergistic Effects for Healing of Wounds in Burn Patients 2023-07-23 anticipated 50 Complete https://irct.ir/trial/71314 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: The patient is unaware of the type of dressing used in each part of the wound, that is, he does not know which dressing is the main group and which is the control group. On the other hand, the surgeon who performs the dressing, the experienced nurse who records the history, and the doctor who evaluates the treatment result are three separate people. In this way, photos and histories are prepared and coded according to the checklist of the intervention and wound control parts at the designated times by the nurse (who is independent from the dressing and evaluator) and the photos are taken by the evaluating doctor who is from The type of dressing used in each photo is unknown, it is checked and the results are recorded. 1 Burn. Intervention 1: Intervention group: This study aims to investigate the effect of chitosan hydrogel containing two antibiotics and its local effect in removing burn damage and accelerating burn wound healing. In this study, the addition of antibiotics (colistin and meropenem at 8 and 4 μg/liter, respectively) to chitosan hydrogel dressing is evaluated. and then covered with sores. If the wound has a lot of exudate, the wound is changed every day. In cases of low exudate, the dressing is changed every three days. In addition, for the coordination and proper implementation of the project, 2 training sessions were held for 4 hours between the technical team and the manufacturer of chitosan wound dressing and the treatment staff of Zare Hospital. Intervention 2: Sulfadiazine antibacterial dressing. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Amir Mellati
Mazandaran University of Medical Sciences, 18 km of Farah Abad road
Sari Iran (Islamic Republic of) ۴۸۱۵۷۳۳۹۷۱ +98 11 3304 4000 amirmellati@gmail.com Mazandaran University of Medical Sciences scientific Amir Mellati
18th km of Farah Abad Road, Mazandaran University of Medical Sciences
Sari Iran (Islamic Republic of) ۴۸۱۵۷۳۳۹۷۱ +98 11 3304 4000 amirmellati@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with 2nd degree burns whose wounds have secretory. exudate The size of the wound is greater than or equal to 10 cm. The location and shape of the wound should be such that it can be divided into two separate areas. No more than a week has passed since the patients were hospitalized. no limit no limit Both Burn wounds without secretory exudate Electrical, chemical and frostbite burns Patients who have used commercial treatments other than the conventional method. Patients with systemic blood problems, kidney, liver and heart problems, and diabetic patients L99 سایر اختلالات پوست و بافت زیر جلدی در بیماری هایی که در جای دیگر طبقه بندی شده اند Treatment - Drugs Treatment - Drugs Intervention group: This study aims to investigate the effect of chitosan hydrogel containing two antibiotics and its local effect in removing burn damage and accelerating burn wound healing. In this study, the addition of antibiotics (colistin and meropenem at 8 and 4 μg/liter, respectively) to chitosan hydrogel dressing is evaluated. and then covered with sores. If the wound has a lot of exudate, the wound is changed every day. In cases of low exudate, the dressing is changed every three days. In addition, for the coordination and proper implementation of the project, 2 training sessions were held for 4 hours between the technical team and the manufacturer of chitosan wound dressing and the treatment staff of Zare Hospital. Sulfadiazine antibacterial dressing Wound healing. Timepoint: At the beginning of the study (before the start of the intervention) and then every 3 days for 21 days. Method of measurement: Wounds are evaluated during the 21-day treatment period. On day zero, biopsy and exudate are taken from the wound and bacterial culture is performed. Then every 6 days, exudate samples are taken from the wound and bacterial culture is done to record the bacteria count by colony counting method. Wounds are photographed every 3 days and redness, inflammation and pain are recorded according to the checklist. The healing percentage is calculated with the following formula: Healing percentage in the wound (%) = ((area before treatment - area after treatment)/area before treatment) * 100. Mazandaran University of Medical Sciences Approved 2022-01-10 Ethics Working Group in Biomedical Research Mazandaran University of Medical Sciences Mazandaran university of Medical Sciences ,Km 18 Farah Abad, Sari Sari Mazandaran Iran (Islamic Republic of)