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IRCT20210920052524N2 IRCT 2021-12-01 Rasht University of Medical Sciences Study of Safety and Efficacy of mitochondrial transplantation extracted from platelets on grade 3 degree burn; Clinical trial Phase I and II Study of Safety and Efficacy of mitochondrial transplantation extracted from platelets on grade 3 degree burn; Clinical trial Phase I and II 2021-11-22 anticipated 30 Complete https://irct.ir/trial/60004 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, in order to allocate patients to intervention and control groups, the limited randomization approach will be used as a block randomization method. To prevent the clarification of the last allocation in the blocks, the size of blocks will be considered 4 or 6 randomly, Blinding description: The patients is blind in this study. In addition, the doctor that evaluates and collects the outcomes is blind. 1-2 Condition 1: burn (3th grade). Condition 2: burn (3th grade). Condition 3: burn (3th grade). Condition 4: burn (3th grade). Condition 5: burn (3th grade). Condition 6: burn (3th grade). Intervention 1: Control group: In the control group, the needle is inserted only to a depth of 1 to 2 mm with no injection. Intervention 2: Intervention group: In the intervention group, transplantation of platelets derived mitochondria is used. Yes - There is a plan to make this available What will be shared: All data including the primary and secondary outcomes are shared. When: After publishing the results in the article To whom: Universities Conditions: Only for study Where to obtain: Dr.Mehryar Habibi Roudkenar Email: roudkenar@gums.ac.ir How to obtain: The request must be written to the Vice Chancellor for Research of Guilan University of Medical Sciences. The request is sent to the principal investigator and the researcher will send the documents to the deputy. The applicant can receive the documents from the deputy. Comments:
public Mehryar Habibi Roudkenar
3th floor, Burn and Regenerative Medicine Research Center, Velayat Hospital, Namjo street, Rasht, Guilan
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Roudkenar@gums.ac.ir Rasht University of Medical Sciences scientific Mehryar Habibi Roudkenar
3th floor, Burn and Regenerative Medicine Research Center, Velayat Hospital, Namjo street, Rasht, Guilan
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Roudkenar@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Age range should be 18 to 65 years Acute burns should be occurred less than 24 hours Percentage of Burn should be 20 to 60. The patient should be capable to fill out the informed consent. 18 years 65 years Both The patient should have severe hypertension ( 90/160≥BP mmHg). The Cardiac troponin level should be high. The patient is pregnant. There are severe underlying diseases. The patient has peripheral vascular disease. The patient has an inhalation injury. The patient has Burn shock (including decreased cardiac output, increased vascular resistance, hypovolemia, and hypoperfusion following severe burn). The Patient has Known inflammatory disease. The patient has undergone off-pump surgery. T20 T21 T22 T23 T24 T25 Burn of unspecified degree of unspecified site of lower limb, except ankle and foot Burn and corrosion of trunk Burn and corrosion of shoulder and upper limb, except wrist and hand Burn and corrosion of wrist and hand Burn and corrosion of lower limb, except ankle and foot Burn and corrosion of ankle and foot Treatment - Other Treatment - Other Control group: In the control group, the needle is inserted only to a depth of 1 to 2 mm with no injection. Intervention group: In the intervention group, transplantation of platelets derived mitochondria is used. Ratio of Graft to burn percentage is detected. Timepoint: At the admission. Method of measurement: Measurement based on Wallace criteria. Total fluid receive. Timepoint: At discharge. Method of measurement: It would be recoded based on patients' files. Hospital stay. Timepoint: At discharge. Method of measurement: It would be recorded based on patients' files. Final clinical outcome. Timepoint: At discharge. Method of measurement: It would be detected based on patients' files. The rate of infection is reduced. Timepoint: The evaluation is performed on days 1, 3, 7, 14 and 28 post burn. Method of measurement: Based on evaluators examination. Itching. Timepoint: The evaluation is performed on days 1, 3, 7, 14 and 28 post burn. Method of measurement: By asking patients. The patient's burning rate decreases. Timepoint: The evaluation is performed on days 1, 3, 7, 14 and 28 post burn. Method of measurement: By asking patients. Shock index. Timepoint: The evaluation is performed on 1,6,12 and14 post burn. Method of measurement: It is measured by heartbeat per minute / systolic Blood pressure in mmHg. SIRS (Systemic inflammatory response syndrome) is reduced. Timepoint: The evaluation is performed on days 1, 3, 7, 14 and 28 post burn. Method of measurement: It is measured based on body temperature, heart rate, respiratory rate, and WBC number (white blood cells) count. Cr (creatinine) level. Timepoint: The evaluation is performed on days 1, 3, 7, 14 and 28 post burn. Method of measurement: Based on patients' laboratory test results. Rasht University of Medical Sciences Approved 2021-10-26 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)