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IRCT20200127046282N17 IRCT 2022-06-02 Skin and Stem cell Research Center of Tehran University of Medical Sciences Evaluation of the effectiveness of wound dressing based on gelatin/chitosan hydrogel to accelerate wound healing Fabrication and evaluation of the effectiveness of the new generation of wound dressings based on Gelatin/Chitosan hydrogel containing nanoparticles and mesenchymal stem cells derived condition medium to accelerate the healing of wounds (phase 1 & II clinical trial) 2022-06-22 anticipated 30 Complete https://irct.ir/trial/63473 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are divided into three groups based on a simple randomization method using a random number table. In this method, a set of non-patterned numbers is randomly generated and converted into a table. Each of the 30 patients in the study has a random number. The number of each person in measure 3 is equal to zero, one or two. Module zero will be the intervention group, module one and two of each control group, Blinding description: 30 patients are divided into three groups of 10 to study. The study groups will include 10 people receiving medium conditioned wounds, 10 people receiving medium conditioned wounds and 10 people receiving standard treatment. 1-2 Burn and wound. Intervention 1: Control group: Ten people will receive standard treatment. Intervention 2: Control group: Ten people will receive non-conditioned wound dressings. Intervention 3: Intervention group: Ten people will receive medium-conditioned wounds. 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 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 0031 m.dahmardehei@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients 18-50 years Patients with grade 2 burns 18 years 50 years Both Patients with chronic inflammatory diseases Patients with impaired immune system T23.2 Burn of second degree of wrist and hand Treatment - Other Treatment - Other Treatment - Other Control group: Ten people will receive standard treatment. Control group: Ten people will receive non-conditioned wound dressings. Intervention group: Ten people will receive medium-conditioned wounds. 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: Software Image J. Pain from burn wounds. Timepoint: Six days after the first intervention. Method of measurement: In the form of questions and answers from the patient. Skin and Stem cell Research Center of Tehran University of Medical Sciences Approved 2022-05-11 Research Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Keshavarz blvd Tehran Tehran Iran (Islamic Republic of)