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IRCT20231209060308N1 IRCT 2024-01-12 Iran University of Medical Sciences Effect of Platelet Injection on Burn Scar Comparing the Effect of Platelet Rich Fibrin Injection with Microneedling Versus Normal Saline Injection with Microneedling in the Treatment of Atrophic Burn Scars: A Randomized Clinical Trial 2024-02-20 anticipated 21 Complete https://irct.ir/trial/74587 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Due to the necessity of ensuring that patients are not deprived of effective scar treatment, all scars will undergo standard treatment involving collagen stimulation with microneedling. Microneedling will be performed using Dermapen, which has disposable needles at the end. The length of these needles will be set at 1.5-2 millimeters, and the device speed will be set to high speed. The device will be moved perpendicular to the scar, covering the entire scar, to induce pinpoint bleeding.For the preparation of Injectable PRF, the standard centrifugation method introduced by Miron et al. will be employed. Blood will be centrifuged for 3 minutes at a gravitational acceleration of 60. Depending on the physician's judgment and the extent of the scar, the desired volume of PRF will be obtained by drawing blood from the patient at a rate of two and a half times the desired PRF volume. Subsequently, the patient's collected blood will be evenly divided into two test tubes and placed in the centrifuge device in a symmetrical arrangement. Following the device settings protocol with gravitational acceleration (g) set at 60, and the number of revolutions per minute (rpm) variable depending on the device, centrifugation will be performed for 3 minutes. The resulting composition will include blood cells at the bottom of the tube and PRF at the top. The separated PRF will then be injected intradermally into the scar on the treatment arm before coagulation.Additionally, normal saline solution will be used for injection into the control arm to blind the patient. Since there is no study proving the effect of normal saline in the collagen synthesis process and similar use in other studies, it is considered a suitable substance for patient blinding, Randomization description: For randomization in this study, the block balanced randomization method will be utilized. Accordingly, we prepare packets for the number of patients, and within each packet, we allocate the treatment and control arms alternately to the right and left side of the face. For instance, in the first packet, the treatment arm for the right hand scar and the control arm for the left hand scar, and in the next packet, this arrangement will be reversed. To ensure that only the evaluator is aware of the arms, abbreviated symbols such as A and B will be used on each paper. Then, when the patient visits, they will be asked to choose one of the packets, and based on their selection, the treatment and control arms will be determined. Thus, at the end of the study, each body part in half of the patients will be in the treatment arm, and in the other half, it will be in the control arm, Blinding description: Clinical Caregiver and Evaluator Blinding: In this study, the role of the clinical caregiver and evaluator is assigned to one person, who also serves as the primary physician of the patient. For blinding, no information related to the treatment and control arms is provided during any of the initial assessment stages and follow-up sessions, which occur one month and three months after the treatment. The physician is required to evaluate the patient's scar without knowledge of these two arms. Participant Blinding: To blind the participants regarding the treatment and control arms, normal saline solution is injected instead of PRF in the control arm. Due to the color difference between these two substances (PRF and normal saline), patients are requested to close their eyes for greater comfort during the injection process. With this method, the patient will not be aware of the color difference between the two injected substances. 3 Burn scar. Intervention 1: Control group: Receiving microneedling along with injection of normal saline. Intervention 2: Intervention group: Receiving microneedling along with injection of platelet-rich fibrin into the specific scar area on the treatment arm, derived from the patient's blood processed in a centrifuge set on 60G. Yes - There is a plan to make this available What will be shared: Non-identifiable patient data will be made available after analysis in the article extracted from the accessible study. These include demographic data and changes in variables related to patients' burn scar. When: Immediately after the publication of the article. To whom: Aggregate data will be accessible for all individuals. Individual data, upon request, will be provided by the corresponding author. Conditions: All investigations leading to the improvement of the research project's outcomes and the advancement of burn scar treatment are feasible. Where to obtain: Email should be sent to the corresponding author in the article. How to obtain: The requester should introduce themselves, specify the type of data requested, provide the reason for the request, and outline the investigations they would like to conduct in their message. Comments:
public Farzan Moodi
Unit 3, No. 14, 33rd street, Gisha
Tehran Iran (Islamic Republic of) 1447934161 +98 21 8601 7501 dr.farzanmoodi@gmail.com Iran University of Medical Sciences scientific Farzan Moodi
Unit 3, No. 14, 33rd street, Gisha
Tehran Iran (Islamic Republic of) 1447934161 +98 915 771 7179 dr.farzanmoodi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Presence of at least two atrophic burn scars anywhere on the body in a symmetrical pattern. Age between 18-60 years. Both male and female genders are included in this study. 18 years 60 years Both Patients with underlying conditions such as diabetes, blood clotting disorders, and immunodeficiency disorders. Pregnant patients or those planning to become pregnant. Patients diagnosed with any malignancy. Smokers with more than one pack of cigarettes per day (Heavy Smokers) Patients who have received another treatment for their scars within the 3-month period prior to the commencement of the intervention, which may have led to collagen stimulation. Patients who do not have the mental capacity to provide consent for participation in the study or to respond to researchers' inquiries. L90.5 Scar conditions and fibrosis of skin Placebo Treatment - Other Control group: Receiving microneedling along with injection of normal saline. Intervention group: Receiving microneedling along with injection of platelet-rich fibrin into the specific scar area on the treatment arm, derived from the patient's blood processed in a centrifuge set on 60G. Patient and Observer Scar Assessment Scale (POSAS) points. Timepoint: In the first visit, the initial treatment session, one month, and three months after the last treatment session. Method of measurement: Patient and Observer Scar Assessment Scale (POSAS). Changes in skin tone evenness. Timepoint: In the initial treatment session, one month, and three months after the last treatment session. Method of measurement: VisioFace. Local inflammatory or irritating adverse events. Timepoint: Within two weeks after each treatment session. Method of measurement: Patient visit or report. Hemosiderin staining. Timepoint: Within two weeks after each treatment session. Method of measurement: Patient visit or report. Herpes. Timepoint: Within two weeks after each treatment session. Method of measurement: Patient visit or report. Hypersensitivity reactions. Timepoint: Within two weeks after each treatment session. Method of measurement: Patient visit or report. Center for Applied Research, Deputy of Health, Relief, and Treatment, NAJA Approved 2023-12-09 Research Ethics Committees of Directorate of Health, Rescue and Treatment of Police Headquarter of I Health, Relief, and Treatment Deputy of NAJA, Edward Brown Street, North Karegar Street, Enqelab Square Tehran Tehran Iran (Islamic Republic of)