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IRCT20210112050019N1 IRCT 2021-08-24 Tabriz University of Medical Sciences Effects of the acellular dermal matrix on skin wound healing: A pilot clinical trial study Effects of the acellular dermal matrix on skin wound healing: A pilot clinical trial study 2021-06-16 anticipated 30 Complete https://irct.ir/trial/55367 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced blocked randomization (BBR) (Block size=4) will be used in the present study to assign the individuals to the intervention (receiving acellular dermal matrix) and control groups, respectively. The sequences generated by BBR using Random Allocation Software (RAS) will be preserved by epidemiologist and it will not be accessible/predictable for other individual involved in the study. Hence, allocation concealment will be assured. Notably, 15 individuals will be included into the each group and effectiveness of BBR on balancing the distribution of potential confounders across the study groups will be assessed. N/A The effect of acellular skin matrix on skin wound healing. Intervention 1: Intervention group: People with skin lesions due to burns, skin injuries, scar tissue caused by injuries. Initially, the cellular scaffold was prepared from the intestine and for disinfection and desullarization for 2 hours of prastic acid ./1% (C2H4O3 )And 4% ethanol (C2H5OH) and 96% distilled water were used and finally the cellular scaffold was washed twice with saline phosphate buffer (PBS) and twice with distilled water. They are the manufacturer of Iranian consumables, then in the culture plate. Cell (DMEM) was placed to culture the cells, after which the dermatologist attached the cell fragments to the areas with skin lesions once to evaluate the results. Intervention 2: Control group: Does not receive any intervention. Yes - There is a plan to make this available What will be shared: By publishing an article When: Start access after 3 months of printing results To whom: Researchers and professors of all universities Conditions: They are allowed access if there is no scientific theft Where to obtain: If the article is published via email to the responsible author How to obtain: In the shortest possible time after contacting the responsible author Comments:
public Dr.Leila Roshanghar
Azadi St., Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 3870 lroshangar@yahoo.com Tabriz University of Medical Sciences scientific Dr.Leila Roshangar
Azadi St., Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 3870 lroshangar@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with second-degree burns. no limit no limit Both Existence of autoimmune diseases Existence of high blood pressure Existence of diabetes L99 Other disorders of skin and subcutaneous tissue in diseases classified elsewhere Treatment - Surgery Treatment - Surgery Intervention group: People with skin lesions due to burns, skin injuries, scar tissue caused by injuries. Initially, the cellular scaffold was prepared from the intestine and for disinfection and desullarization for 2 hours of prastic acid ./1% (C2H4O3 )And 4% ethanol (C2H5OH) and 96% distilled water were used and finally the cellular scaffold was washed twice with saline phosphate buffer (PBS) and twice with distilled water. They are the manufacturer of Iranian consumables, then in the culture plate. Cell (DMEM) was placed to culture the cells, after which the dermatologist attached the cell fragments to the areas with skin lesions once to evaluate the results. Control group: Does not receive any intervention. Percentage of people who have burns. Timepoint: Healing of skin ulcers at the beginning of the study and 21 days after the start of the clinical trial. Method of measurement: Skin Wound Healing Questionnaire. Tabriz University of Medical Sciences Approved 2021-05-31 Tabriz Ethics Committee of Medical Sciences Azadi St., next to Imam Reza Hospital, Tabriz University of Medical Sciences tabriz East Azarbaijan Iran (Islamic Republic of)