]>
IRCT20241028063523N2 IRCT 2024-11-12 Armed forces Hospital PNS Shifa karachi,Pakistan Comparison of efficacy of combined intralesional steroid and cryotherapy versus intralesional steroid alone in treatment of keloid. Comparison of efficacy of combined intralesional steroid and cryotherapy versus intralesional steroid alone in treatment of keloid. 2024-11-04 anticipated 64 Complete https://irct.ir/trial/79955 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This will be a hospital based randomized control interventional study consisting of 64 patients ( 32 in each group), Randomization description: The keloid patients will randomly be divided into two groups by lottery method which will be administered two different treatment regimens. patient scar will be assessed by Vancouver scar scale. 4 Keloids. Intervention 1: There are no control group there two interventional group. 1. Group A will have 32 patients and the will be receive intralesional steroid treatment in conjunction with cryotherapy. In this group, patients will undergo cryotherapy using liquid nitrogen gas, applied until a freezing halo appears. This procedure will occur over two sessions. After the second thaw, patients will receive the intralesional steroid triamcinolone acetonide trade name ( injection K-cort ampule manufacturer -pharma( pvt) Ltd at a concentration of 40 mg/ml, administered at a dosage of 0.1 ml per cm², not to exceed 1 ml per lesion at baseline and 4 weeks 8 weeks 12 weeks. Treatment responses for both groups will be evaluated using the Vancouver Scar Scale, along with subjective assessments from the patients. The response of treatment shall be entered in pre designed to asses the efficacy of two therapeutic agents . the data will be analyzed using SPSS version 23. Intervention 2: Intervention group: 2. Group B 32 will have and they will be receive only the intralesional steroid, triamcinolone acetonide trade name injection K-cort ampule manufacturer-pharma (Pvt.) Ltd, also at a concentration of 40 mg/ml, with the same dosing parameters as Group A (0.1 ml per cm², not exceeding 1 ml per lesion). at baseline and 4 weeks 8 weeks 12 weeks. Treatment responses for both groups will be evaluated using the Vancouver Scar Scale, along with subjective assessments from the patients. The response of treatment shall be entered in pre designed to asses the efficacy of two therapeutic agents . the data will be analyzed using SPSS version 23. Yes - There is a plan to make this available What will be shared: Comparison of efficacy of combined intralesional steroid and cryotherapy versus intralesional steroid alone in the treatment of keloid. When: From may 2025, and it will be available lifelong To whom: It will be available for all healthcare professionals. Conditions: Original article Where to obtain: sadia.abbasi038@gmail.com How to obtain: Can contact via the above email ID. Comments:
public Dr Sadia D/O Sardar Ahmed Abbasi
DHA phase ll, PNS Shifa hospital, near Kala pul.
Karachi Pakistan 75500 +92 21 48506540 sadia.abbasi038@gmail.com PNS Shifa scientific Dr Sadia D/O Sardar Ahmed Abbasi
DHA phase ll, PNS Shifa hospital, near kala pul.
Karachi Pakistan 75500 +92 21 48506540 sadia.abbasi038@gmail.com PNS Shifa Pakistan Patient of either gender, Having single or multiple keloids of size not more than 10 cm Between 12 to 60 years of age Willing to sign informed consent 12 years 60 years Both Patient with infected keloids Co existing inflammatory skin diseases Unrealistic expectations or with psychiatric illnesses Pre existing bleeding disorders. Renal disease and hepatic disease. Lactating / pregnant women. Immunodeficient patients , diseases that react adversely to cold (Raynaud's disease, cryoglobulinemia , cold urticaria ) and with wound healing abnormalities will be excluded. L73.0 Keloids are dermal proliferations of fibrous tissue that often arise at sites of cutaneous injury and have significant impact on quality of life Treatment - Drugs Treatment - Drugs There are no control group there two interventional group. 1. Group A will have 32 patients and the will be receive intralesional steroid treatment in conjunction with cryotherapy. In this group, patients will undergo cryotherapy using liquid nitrogen gas, applied until a freezing halo appears. This procedure will occur over two sessions. After the second thaw, patients will receive the intralesional steroid triamcinolone acetonide trade name ( injection K-cort ampule manufacturer -pharma( pvt) Ltd at a concentration of 40 mg/ml, administered at a dosage of 0.1 ml per cm², not to exceed 1 ml per lesion at baseline and 4 weeks 8 weeks 12 weeks. Treatment responses for both groups will be evaluated using the Vancouver Scar Scale, along with subjective assessments from the patients. The response of treatment shall be entered in pre designed to asses the efficacy of two therapeutic agents . the data will be analyzed using SPSS version 23. Intervention group: 2. Group B 32 will have and they will be receive only the intralesional steroid, triamcinolone acetonide trade name injection K-cort ampule manufacturer-pharma (Pvt.) Ltd, also at a concentration of 40 mg/ml, with the same dosing parameters as Group A (0.1 ml per cm², not exceeding 1 ml per lesion). at baseline and 4 weeks 8 weeks 12 weeks. Treatment responses for both groups will be evaluated using the Vancouver Scar Scale, along with subjective assessments from the patients. The response of treatment shall be entered in pre designed to asses the efficacy of two therapeutic agents . the data will be analyzed using SPSS version 23. The primary outcome of the study will focus on changes in scar appearance, measured using the Vancouver Scar Scale. This scale evaluates several parameters, including pigmentation, pliability, height, and vascularity, providing a comprehensive assessment of treatment effectiveness. Additionally, patient-reported outcomes will be assessed through the Patient Scar Assessment Scale, specifically evaluating improvements in scar perception, including aspects such as pain, itching, color, stiffness, and thickness, as well as overall patient satisfaction with the appearance of their keloids. Timepoint: Patient will be assessed at baseline and 4 weeks, 8 weeks , 12 weeks. Method of measurement: Vancouver scar scale and Patient Scar Assessment Scale. Secondary outcomes will be evaluated to enhance understanding of treatment efficacy. These include the recurrence rate of keloids, the time to noticeable improvement in scar characteristics, and the incidence of adverse effects in both groups. The study will also assess the impact of treatments on overall quality of life using standardized questionnaires, gather additional patient satisfaction scores, and analyze changes in scar morphology through vancouver scar scale assessments taken before and after treatment. Timepoint: Patient will be assessed at baseline 4 weeks , 8 weeks , 12 weeks. Method of measurement: Patient scar will be assessed by vancouver scar scale and subjective assessment noticed by patients themselves will be assessed by patient scar assessment scale . Armed Forces Approved 2024-04-04 Ethical committee PNS shifa DHA phase ll, PNS Shifa hospital near kala pul. Karachi Sindh Pakistan