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IRCT20160117026069N6 IRCT 2023-01-26 Karaj University of Medical Sciences Bacterial nanocellulose wound dressings for the healing of second degree burn wounds Comparison of bacterial nanocellulose wound dressings and standard treatment in the healing of second degree burn wounds: a randomized controlled clinical trial 2023-02-20 anticipated 24 Complete https://irct.ir/trial/68182 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sealed envelopes are considered as the number of patients, whose content determines which group each person belongs to. One of these envelopes is selected for each patient by lottery, and then this envelope is opened and the allocation of the patient will be determined after opening the envelopes. 3 Second degree burn ulcer. Intervention 1: Intervention group: After preliminary and necessary measures such as washing and disinfecting the wound, nanocellulose coating is placed on the wound and covered with a sterile gauze. In this group, the dressing will be changed every three days without removing the nanocellulose dressing. Intervention 2: Control group: After preliminary and necessary measures such as washing and disinfecting the wound, the dressing is done using usual ointments (usual treatment) and the whole dressing is changed once every three to five days. Yes - There is a plan to make this available What will be shared: All of the participants' individual data When: Access starts 6 months after results are published To whom: All researchers working in academic and scientific institutions and people working in the industry Conditions: If a request with this theme is received, a decision will be made with the opinion of the research team. Where to obtain: To the project manager, Dr. Hadi Pourjafar How to obtain: After submitting the request to the project manager, this request will be reviewed by a committee with the presence of all the people involved in the project, and then if the committee gives a positive answer, the data will be provided to the applicant. Comments:
public Hadi Pourjafar
Vice-Chancellor for Research and Technology, Gulshahr, Safarian Alley
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3464 3705 pourjafarhadi59@gmail.com Karaj University of Medical Sciences scientific Leila Hajimaghsoudi
Shahid Madani medical eduction and treatment center, Shahid Madani Sq., Shahid Madani Blvd., Talegani Ave.
Karaj Iran (Islamic Republic of) 3143744693 +98 26 3442 7001 L.hajimaghsoudi@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Having second degree burns on the limbs or trunk (with TBSA below 10%) 18 years 75 years Both Pregnancy Chronic heart, kidney and liver diseases Wound infection Systematic cortisone use M61.3 Calcification and ossification of muscles associated with burns Treatment - Other Other Intervention group: After preliminary and necessary measures such as washing and disinfecting the wound, nanocellulose coating is placed on the wound and covered with a sterile gauze. In this group, the dressing will be changed every three days without removing the nanocellulose dressing. Control group: After preliminary and necessary measures such as washing and disinfecting the wound, the dressing is done using usual ointments (usual treatment) and the whole dressing is changed once every three to five days. Duration of hospitalization. Timepoint: When the patient discharged from the hospital. Method of measurement: Information recorded in the patient file. Duration of recovery. Timepoint: Daily until hospitalization and weekly visits thereafter. Method of measurement: Observation of the physician. Wound infection. Timepoint: Daily during hospitalization and weekly visits thereafter. Method of measurement: Observation of the physician. Hypertrophic scar. Timepoint: The last visit. Method of measurement: Observation of the physician. Patient satisfaction. Timepoint: The last visit. Method of measurement: Questioning the patient in the form of yes or no. Pain. Timepoint: First day, second day, third day. Method of measurement: Asking the patient based on the VAS scale. Itching. Timepoint: First day, second day, third day. Method of measurement: Asking the patient based on the VAS scale. Karaj University of Medical Sciences Approved 2023-01-08 Ethics committee of Alborz University of Medical Sciences Saffarian Alley, Golshahr Blvd, Karaj Karaj Alborz Iran (Islamic Republic of)