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IRCT20161001030072N4 IRCT 2023-10-04 Rasht University of Medical Sciences Investigation of the effect of hydrogel wound dressing based on polyacrylic acid and xanthan gum in the treatment of burn injury Evaluation of safety and efficacy of hydrogel wound dressing based on polyacrylic acid and xanthan gums in patients with 2nd thickness burns (Clinical trial phase II) 2023-10-02 anticipated 42 Complete https://irct.ir/trial/72664 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, in order to assign patients to the intervention and control groups, the restricted randomization approach will be used in parallel with the Random Allocation Rule method. In the random assignment process, the person who creates the random sequence is the analyst in this study. Also, the person who registers the participants based on the entry and exit criteria in the study will be one of the clinic nurses, and the person who allocates the participants in the intervention and control groups will be the project manager. 3 Second degree burn. Intervention 1: Intervention group: Before strarting the study, patients wound are examined by a doctor based on a checklist. Wounds are first washed with normal saline, Then a hydrogel dressing based on polyacrylic acid and xanthan gum (Masiha Eltiam Gostaran company) is placed on the wound and bandaged with sterile gauze. Burning parameter changes will be measured before intervention and at the end of 1, 3, 7, 14 and 28 days. Intervention 2: Control group: Before studying, the patient's wounds are examined by a doctor based on a checklist. Wounds are first washed with normal saline, Then commercial hydrogel dressing (Burntec) is placed on the wound and bandaged with sterile gauze. Burning parameter changes will be measured before hydrogel applying and at the end of 1,3,7, 14, and 28 days. 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 -
public Mohammad Reza Mobayen
3rd floor, Burn and Regenerative Medicine Research Center, Velayat Hospital, Namjo street, Rasht, Guilan
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Maziar.mobayen@gmail.com Rasht University of Medical Sciences scientific Dr. Mohammad Reza Mobayen
3th floor, Burn and Regenerative Medicine Research Center, Velayat Hospital, Namjo street, Rasht, Guilan
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Maziar.mobayen@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Thermal burns with flame or boiling water Second degree burns Burn percent range Between 20-50% Refer to the treatment center within less than 24 hours after the burn Normal hemoglobin and total protein levels are normal Male or female patients in age range 18 to 65 years Written consent form by the patients Body mass index between 18-30 kg/m2 18 years 65 years Both Having background diseases ( anemia, diabetes, cardiovascular diseases, immunodeficiency disorder) Lactating women Pregnant women T20.0 Burn of unspecified degree of head, face, and neck Treatment - Other Treatment - Other Intervention group: Before strarting the study, patients wound are examined by a doctor based on a checklist. Wounds are first washed with normal saline, Then a hydrogel dressing based on polyacrylic acid and xanthan gum (Masiha Eltiam Gostaran company) is placed on the wound and bandaged with sterile gauze. Burning parameter changes will be measured before intervention and at the end of 1, 3, 7, 14 and 28 days. Control group: Before studying, the patient's wounds are examined by a doctor based on a checklist. Wounds are first washed with normal saline, Then commercial hydrogel dressing (Burntec) is placed on the wound and bandaged with sterile gauze. Burning parameter changes will be measured before hydrogel applying and at the end of 1,3,7, 14, and 28 days. Local out comes. Timepoint: At the beginning of the study (before the intervention) and 1, 3, 7, 14 and 28 days after applying the hydrogel wound dressing. Method of measurement: Clinical observations and filling the checklist in 6 time points. Systemic outcomes. Timepoint: At the beginning of the study (before the intervention) and 1, 3, 7, 14 and 28 days after applying the hydrogel wound dressing. Method of measurement: Clinical observations and filling the checklist in 6 time points. Infection. Timepoint: At the beginning of the study (before the intervention) and 1, 3, 7,14, and 28 days after applying the hydrogel wound dressing. Method of measurement: Based on examination done by evaluators. Hospital stay. Timepoint: At discharge. Method of measurement: Based on patients' files. Total fluid requirement. Timepoint: At discharge. Method of measurement: Based on patients' files. Graft to TBSA (total body surface area) percent ratio. Timepoint: At the admission. Method of measurement: Measurements based on Wallace criteria. Rasht University of Medical Sciences Approved 2023-09-13 Ethics committee of Guilan University of Medical Sciences 3rd floor, Burn and Regenerative Medicine Research Center, Velayat Hospital, Namjo street, Rasht, Guilan Rasht Guilan Iran (Islamic Republic of)