]>
IRCT20240614062129N1 IRCT 2024-10-10 Arak University of Medical Sciences Comparison of efficacy of carboxytherapy and intralesional injection of triamcinolone in the treatment of keloid Comparison of efficacy of carboxytherapy and intralesional injection of triamcinolone in the treatment of keloid: a randomized 2-split clinical trial 2024-09-15 anticipated 17 Complete https://irct.ir/trial/77571 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Coin toss method are used to determine the side of intervention and control. In this method, the back of the coin is considered as intervention and the face of the coin is considered as control. One side of the body is allocated to carboxytherapy by tossing a coin, and the other side to triamcinolone injection. During the study, the side of treatment with carboxytherapy or triamcinolone remains constant, Blinding description: The present study is single-blind. Except for the first executive of the plan (Dr. Noushin Bagherani), who is fully aware of the treatment groups and promotes the treatment herself, the other executives of the plan do not know about the groupings. Uninformed facilitators examine the response to treatment, and data is collected by the student, who is unaware of the treatment group, and delivered to the principal facilitator of the plan. Patients are informed about the treatment method, but they are requested not to give any information about the treatment method. N/A Keloid lesions. Intervention 1: Intervention group: Carboxytherapy. In the intervention group, carboxytherapy is performed by injecting 2 cc of Co2 gas into the lesion for every square centimeter of colloid by the MEDAION carboxytherapy device, made in Iran, Nik Fanavaran Plasma Company. The gas is injected at a rate of half a cc per shot and at a temperature of 40 degrees Celsius. Injections will continue weekly for 8 weeks. Intervention 2: Control group: Intralesional injection of triamcinolone . In the control group, two units of triamcinolone acetonide diluted in lidocaine with a concentration of 20 mg/ml are injected from an insulin syringe at 4-week intervals. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals. The data related to the main outcome of the study results will be published in general and without mentioning the names of the individuals. When: The access period begins after the results are printed. To whom: The data will be available to researchers working in academic, scientific institutions and researchers working in industry. Conditions: All cases of using documents related to published data should be with reference to the original article and the authors of the article. Also, if there is a need to access the photos of the patients' lesions, written consent will be received from them and the patients' eyes will be covered so that they cannot be identified. Where to obtain: Applicants can contact the authors of the article to receive the desired data at the email address of Dr. Noushin Bagherani at the following address. nooshinbagherani@yahoo.com How to obtain: After sending the request to the mentioned e-mail address, your request will be read and checked by Dr. Noushin Bagherani and will be shared with other authors of the article and then it will be answered, which will take approximately 14 days on average. it ends Comments:
public Kimiya Ahmadifar
Arak University of Medical Sciences, Basij Square
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3532 kimiyaahmadifar@gmail.com Arak University of Medical Sciences scientific Nooshin Bagherani
Arak University of Medical Sciences, Basij Square
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3532 nooshinbagherani@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) People have informed consent to participate in the study Patients who are over 12 years old The presence of more than 2 keloid lesions in the trunk or limbs Distribution of lesions on both right and left sides and presence of at least one lesion on each side 12 years no limit Both Absence of pregnancy and breastfeeding No smoking, alcohol and drug abuse Not suffering from systemic diseases such as diabetes, kidney diseases, heart diseases, respiratory diseases, liver diseases, anemia, etc. Not having connective tissue diseases or genodermatosis Treatment - Other Treatment - Drugs Intervention group: Carboxytherapy. In the intervention group, carboxytherapy is performed by injecting 2 cc of Co2 gas into the lesion for every square centimeter of colloid by the MEDAION carboxytherapy device, made in Iran, Nik Fanavaran Plasma Company. The gas is injected at a rate of half a cc per shot and at a temperature of 40 degrees Celsius. Injections will continue weekly for 8 weeks. Control group: Intralesional injection of triamcinolone . In the control group, two units of triamcinolone acetonide diluted in lidocaine with a concentration of 20 mg/ml are injected from an insulin syringe at 4-week intervals. The area of keloid lesions. Timepoint: The area of keloid lesions is measured at the beginning of the study, before each carboxytherapy session and 2 weeks after the last carboxytherapy session. Method of measurement: The area of the keloid lesions is measured with grid paper. For this purpose, we put transparent oil paper on the desired lesion and mark its border. Then we transfer it to checkered paper with carbon paper and estimate the area of the lesion by counting the squares. Height of keloid lesions. Timepoint: The height of keloid lesions is measured at the beginning of the study, before each carboxytherapy session and 2 weeks after the last carboxytherapy session. Method of measurement: The height of the target lesion in the thickest part in the peripheral area is calculated with the help of a ruler. For this purpose, with the help of a caliper, one tip of which is tangent to the base of the keloid and one tip is tangent to its surface, we determine the height of the lesion and adjust the distance between the two tips to the ruler. Patient satisfaction in terms of pain level. Timepoint: Patients' satisfaction in terms of pain level is evaluated during each carboxytherapy session. Method of measurement: The evaluation of pain is done with the Visual Analogue Scale. Arak University of Medical Sciences Approved 2024-06-02 Ethics committee of Arak University of Medical Science Department of Research and Technology, Arak University of Medical Sciences, Basij Square Arak Markazi Iran (Islamic Republic of)