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IRCT20161001030072N3 IRCT 2023-05-10 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 of hydrogel wound dressing based on polyacrylic acid and xanthan gums in patients with 2nd thickness burns (Clinical trial phase I) 2023-05-21 anticipated 6 Complete https://irct.ir/trial/70004 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: -. 1 Second degree burn. In the intervention group: before studying the wound, patients 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 and, 7 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
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 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 less than 10% 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 Burn and corrosion of head, face, and neck Treatment - Other In the intervention group: before studying the wound, patients 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 and, 7 days. Local out comes. Timepoint: At the beginning of the study (before the intervention) and 1, 3 and 7 days after applying the hydrogel wound dressing. Method of measurement: Clinical observations and filling the checklist in 4 time points. Systemic outcomes. Timepoint: At the beginning of the study (before the intervention) and 1, 3 and 7 days after applying the hydrogel wound dressing. Method of measurement: Clinical observations and filling the checklist in 4 time points. Rasht University of Medical Sciences Approved 2023-05-02 Ethics committee of Guilan University of Medical Sciences 3th floor, Burn and Regenerative Medicine Research Center, Velayat Hospital, Namjo street, Rasht, Guilan Rasht Guilan Iran (Islamic Republic of)