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IRCT20201005048928N1 IRCT 2022-07-05 Iran University of Medical Sciences Evaluation of the effect and safety of fractional PDL and CO2 lasers on burn scars Evaluation of the efficacy and safety of co2 fractional laser in combination with Pulsed dye laser vs. each one alone in treatment of hypertrophic burn scars: a blinded RCT 2021-02-27 anticipated 60 Complete https://irct.ir/trial/52919 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: The randomization method is to prepare a random list in the form of random blocks with a volume of 60 that patients are divided into three groups (2 intervention groups and a control group). The random list will be generated by the statistician of the project and will be provided directly to the main executor of the project. It should be noted that the patient randomization list is prepared by NCSS PASS11. Using the Procedures menu, the DOE submenu and select the desired method in the Randomization list will be done, Blinding description: The present study is a clinical trial study with three arms and one blind side. The main performer (Dr. Godarzi) performs the treatment for patients with fractional co2 lasers or PDL lasers or a combination of both treatments depending on the group of patients in which the patient is placed. The results of the interventions are evaluated by a secondary assessor who is a dermatologist (Dr. Rouhani) and she is blind in this study. 3 treatment of hypertrophic or keloidal burn scars. Intervention 1: Control group: Patients in the control group receive a PDL laser with a pulse of 595 nm in first treatment session and this treatment is repeated for up to 3 sessions. The interval between treatment sessions is about 1 month. PDL is performed using the Synchro VasQ laser device, which is made in Italy for deka Alexandrite Company. The device settings are as follows:pulse= 595 nm, power=6.5 J/cm², single duration=0.5 ms , spot size=7mm. Intervention 2: Intervention group 1: Fractional CO2 lasers are performed in first treatment session and repeated up to 3 sessions. The interval between treatment sessions is about 1 month. Fractional Co2 is made using the smartxide2 DOT / RF, both of which are made in Italy for deka Alexandrite. The device settings are as follows: Co2 fractional laser: fractional power =12 J/cm², pulse= 10600 nm, Stack=2 , DT(dwelling time)=800 ms , space=800mm. Intervention 3: Intervention group 2: Combination therapy includes a PDL laser and a fractional co2 laser, both of which are performed in first treatment session and repeated up to 3 sessions. The interval between treatment sessions is about 1 month. PDL is performed using a Synchro VasQ laser and Co2 fractional laser using a smartxide2 DOT / RF device, both of which are made for Deka Alexandria, Italy. The device settings are as follows: Co2 fractional laser: fractional power =12 J/cm² pulse= 10600 nm, Stack=2 , DT(dwelling time)=800 ms , space=800mm² PDL: pulse= 595 nm, power=6.5 J/cm², single duration=0.5 ms , spot size=7mm. Yes - There is a plan to make this available What will be shared: Potential data is sharing after making people undetectable When: One year after the results have been published To whom: only for academic and scientific researchers Conditions: The data can be used for scientific researches . Where to obtain: Maedeh Karimi Kivi, medical student, maedeh.karimi100@yahoo.com How to obtain: After reviewing by the project executor and in consultation with the biostatistics specialist and by keeping the patients' information confidential, the applicant will be provided. Comments:
public Maedeh Karimi Kivi
Unite 4th., NO. 20, East sixth AV., North Allameh street., Saadat Abad
Tehran Iran (Islamic Republic of) 1997856418 +98 21 2207 4375 maedeh.karimi100@yahoo.com Iran University of Medical Sciences scientific Azadeh Goodarzi
Corner of Mansouri Street., Niayesh St., Sattarkhan., Tehran., Iran
Tehran Iran (Islamic Republic of) 1445613131 021-64351 goodarzi.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) All patients with hypertrophic scars caused by burn 10 years 60 years Both Women who are included in the study should not breastfeed Women who are included in the study should not be pregnant Study participants should not have used lasers for the past 1 month. Study participants should not have used topical or injectable corticosteroids in the past 1 month ُStudy participants shouldn't have underlying diseases that interfere with the healing process of the scar; Like diabetes Treatment - Other Treatment - Other Treatment - Other Control group: Patients in the control group receive a PDL laser with a pulse of 595 nm in first treatment session and this treatment is repeated for up to 3 sessions. The interval between treatment sessions is about 1 month. PDL is performed using the Synchro VasQ laser device, which is made in Italy for deka Alexandrite Company. The device settings are as follows:pulse= 595 nm, power=6.5 J/cm², single duration=0.5 ms , spot size=7mm Intervention group 1: Fractional CO2 lasers are performed in first treatment session and repeated up to 3 sessions. The interval between treatment sessions is about 1 month. Fractional Co2 is made using the smartxide2 DOT / RF, both of which are made in Italy for deka Alexandrite. The device settings are as follows: Co2 fractional laser: fractional power =12 J/cm², pulse= 10600 nm, Stack=2 , DT(dwelling time)=800 ms , space=800mm Intervention group 2: Combination therapy includes a PDL laser and a fractional co2 laser, both of which are performed in first treatment session and repeated up to 3 sessions. The interval between treatment sessions is about 1 month. PDL is performed using a Synchro VasQ laser and Co2 fractional laser using a smartxide2 DOT / RF device, both of which are made for Deka Alexandria, Italy. The device settings are as follows: Co2 fractional laser: fractional power =12 J/cm² pulse= 10600 nm, Stack=2 , DT(dwelling time)=800 ms , space=800mm² PDL: pulse= 595 nm, power=6.5 J/cm², single duration=0.5 ms , spot size=7mm Effectiveness of co2 laser fractional + PDL laser vs each one alone in terms of scar improvement. Timepoint: Before starting treatment, 40 days after the last treatment session. Method of measurement: Due to the Total Vancouver Scar Scale, color of the scar, vascular distribution of the scar, flexibility of the scar, height of the scar. CO2 fractional laser + PDL safety in comparison with each alone in terms of scar improvement. Timepoint: 40 days after the last treatment session. Method of measurement: Prolonged pain or burning, prolonged redness or erythema, post-inflammatory hyperpigmentation (PIH) and even laser site infection. Patient's satisfaction with the outcome of treatment. Timepoint: 40 days after the last visit. Method of measurement: questionnaire. Iran University of Medical Sciences Approved 2020-09-22 Ethics committee of Iran University of Medical Sciences Hemmat Highway between Chamran and Sheikh Fazlollah, Iran University of Medical Sciences, 5th Floor Tehran Tehran Iran (Islamic Republic of)