Keloids. Keloids are dermal proliferations of fibrous tissue that often arise at sites of cutaneous injury and have significant impact on quality of life
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 . | — |
Countries
Pakistan
Contacts
PNS Shifa