Clinical trial of the Efficacy of Chitosan Hydrogel Wound dressing Loaded with two Antibiotics with Synergistic Effects for Healing of Wounds in Burn Patients

he evaluation of the safety and efficiency of the chitosan hydrogel system and the investigation of the synergistic effect of the optimized concentrations of antibiotics in preventing the progress of infection and healing the tissue of burn wounds is in phase one of the Clinical Trial.

Clinical trial with control group, with parallel groups, double blind, non- random, phase 1 on 50 patients.

Infectious second degree burn patients are selected from those who refer to Zare Hospital. In this way, all the patients who enter, provided they meet the entry criteria and do not have the exit criteria and complete the consent form until the required number of the study is filled, are accepted and entered the study without exception.

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 can be divided into two separate areas. No more than a week has passed since the patients were hospitalized.

Group A: Wound covered with antibacterial chitosan hydrogel dressing. Group B: wound covered with sulfadiazine antibacterial dressing. In each of the patients, the wounds are treated simultaneously in 2 methods A and B (Within-person RCT), in such a way that depending on the extent of the wound, the wound is divided into two equal parts, left and right or upper and lower.

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 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