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IRCT20220512054831N1 IRCT 2022-07-09 Skin and Stem cell Research Center of Tehran University of Medical Sciences combined efficacy of wound dressing and mesenchymal condition medium on burns Efficacy evaluation of a collagen/PVA wound dressing containing hybrid curcumin/chitosan nanoparticles combined with mesenchymal stem cell condition medium in burn wound (clinical phase 1 & 2) 2022-06-22 anticipated 20 Complete https://irct.ir/trial/63523 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization method using a random number table will be applied. Each patient receives a code between 01 and 20 respectively right after registration.The researcher receives the numbers and randomly starts from one point on the table and proceeds until the the first number with digits between 01 to 20 on the right is seen. This code corresponds to one of the patients and this process repeats until our control group is completed. After that, the 10 remaining patients are categorized as intervention group, Blinding description: In order to make the process blind for clinical operator; packages of wound dressings will be designed with identical shapes and with similar contents which will be indistinguishable. 1-2 Burn and wound. Intervention 1: In the intervention group, collagen dressing containing condition medium soaked PVA nanofibers, loaded with curcumin/chitosan nanospheres will be applied on wounds. Based on animal studies, durability of the dressing is about 6 days but it is renewable until wound closure if it is clinically necessary. The duration of intervention will be 3 weeks. The weight ratio of nanosphere to total wound dressing is 1%. Intervention 2: In control group, an available standard wound dressing based on clinician's prescription in Motahari burns hospital will be applied by following the protocols identically for all patients of group. The description of treatment and protocol will be available in details in the report of the clinical trial. Yes - There is a plan to make this available What will be shared: Only information about the main outcome or the suchlike can be shared. When: Access period 3 months after publication of the report To whom: The data can be made available to research and academic institutions. Conditions: The data can be used for research, industrial and production purposes of medical equipment by observing the intellectual rights of researchers.ق Where to obtain: Rnit101@gmail.com Reza Naser How to obtain: For research purposes, information will be available after a period of one week. For industrial and production purposes, information will be available after receiving and approving the process proposal by researchers. Comments:
public Jafar Ai
No 88, Italia Street, Ghods Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1417755469 +98 21 4305 2000 jafar_ai@tums.ac.ir Tehran University of Medical Sciences scientific Mostafa Dahmardehei
Shahid Motahhari Burn Hospital, Rashid-Yasemi Ave, Valieasr Ave, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1996714353 +98 21 8877 0021 m.dahmardehei@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) second degree burn 18 years 50 years Both Immune disorders, malignancy and underlying conditions such as type 1 diabetes T21.20X Burn of second degree of trunk, unspecified site, initial encounter Treatment - Devices Treatment - Devices In the intervention group, collagen dressing containing condition medium soaked PVA nanofibers, loaded with curcumin/chitosan nanospheres will be applied on wounds. Based on animal studies, durability of the dressing is about 6 days but it is renewable until wound closure if it is clinically necessary. The duration of intervention will be 3 weeks. The weight ratio of nanosphere to total wound dressing is 1%. In control group, an available standard wound dressing based on clinician's prescription in Motahari burns hospital will be applied by following the protocols identically for all patients of group. The description of treatment and protocol will be available in details in the report of the clinical trial. The size of the granulation tissue formed in the wound. Timepoint: Before the intervention and six days after the last intervention. Method of measurement: Wound imaging and analysis using Image J 1.52v software (scientific image processing and analysis software). Wound surface and depth. Timepoint: Before the intervention and six days after the last intervention. Method of measurement: Wound imaging and analysis using Image J 1.52v software (scientific image processing and analysis software). Pain from burn wound. Timepoint: Right before intervention and six days after the first intervention. Method of measurement: questions and answers from the patient. Skin and Stem cell Research Center of Tehran University of Medical Sciences Approved 2022-04-26 Research Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Keshavarz blvd Tehran Tehran Iran (Islamic Republic of)