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IRCT20140624018210N6 IRCT 2018-01-13 Iran University of Medical Sciences Comparison of Microneedeling Therapeutic Effect versus Fractional CO2 Laser in the Treatment of Burn Scars in Patients with Burn Comparison of Microneedeling Therapeutic Effect versus Fractional CO2 Laser in the Treatment of Burn Scars in Patients with Burn 2017-04-21 anticipated 56 Complete https://irct.ir/trial/16594 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block.The randomization unit is individual and randomization's tool is a statistical software, Blinding description: In this study, the Outcome assessor and data analyzer has been blinded. The Outcome assessor is people who are responsible for making assessments on outcomes or gathering data on outcome variables and does not know which treatment is performed on the burned scar. Data analyser is people who analyse the data collected during a trial and they do not know how to treat the participants. N/A Burn scar. Intervention 1: Intervention group: use of microneedeling, three sessions at intervals of 4 to 6 weeks. Intervention 2: Control group: use of fractional co2 laser, three sessions at intervals of 4 to 6 weeks. Yes - There is a plan to make this available What will be shared: Research datas When: Starting 6 months after publication To whom: Dermatologists Conditions: In the case of comparision with other similar trials Where to obtain: Iran university of medical siences How to obtain: Requests for data will be available to applicants upon examination and correspondence in the Dermatology and Library of the Iranian Medical University Comments:
public Dr Mahrokh Fotooei
Hazrat Rasoul Akram Hospital, Niayesh street, Sattarkhan avenue
Tehran Iran (Islamic Republic of) 1313114456 +98 21 6435 2421 mahrokh.fotooei@gmail.com Hazrat Rasoul Akram Hospital scientific Dr Elham Behrangi
Hazrat Rasoul Akram Hospital, Niayesh street, Sattarkhan avenue
Tehran Iran (Islamic Republic of) 1313114456 +98 21 6435 2421 behrangi.e@iums.ac.ir Hazrat Rasoul Akram Hospital Iran (Islamic Republic of) Second and third degree burns The age range is between 15 and 50 years old Lack of previous treatment procedures at the burning scar 15 years 50 years Both Burns with higher grades Skin scars other than burns Symptoms of skin infection in affected areas Intolerance to each of the therapeutic interventions S00-T98 injury, poisoning and certain other consequences of external causes Treatment - Other Treatment - Other Intervention group: use of microneedeling, three sessions at intervals of 4 to 6 weeks Control group: use of fractional co2 laser, three sessions at intervals of 4 to 6 weeks Contracture. Timepoint: Before intervention, every 4 to 6 weeks for 3 session, three months after the last intervention. Method of measurement: Photography, clinical assesment. Height. Timepoint: Before intervention, every 4 to 6 weeks for 3 session, three months after the last intervention. Method of measurement: VSS scoring scale. Color. Timepoint: Before intervention, every 4 to 6 weeks for 3 session, three months after the last intervention. Method of measurement: VSS scoring scale. Pliability. Timepoint: Before intervention, every 4 to 6 weeks for 3 session, three months after the last intervention. Method of measurement: VSS scoring scale. Vascularity. Timepoint: Before intervention, every 4 to 6 weeks for 3 session, three months after the last intervention. Method of measurement: VSS scoring scale. Patient satisfaction. Timepoint: Before intervention, every 4 to 6 weeks for 3 session, three months after the last intervention. Method of measurement: Photography, VAS scale. Iran University of Medical Sciences Approved 2017-04-08 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat highway Tehran Tehran Iran (Islamic Republic of)