Evaluation of the safety and efficacy of pressure-enhanced scar patch in a rabbit ear hypertrophic scar model
摘要
Hypertrophic scars are prevalent fibrotic disorders that arise following skin wound healing, often resulting in both functional impairments and significant cosmetic concerns for affected individuals. Current therapeutic options, with pressure therapy being standard, frequently encounter challenges related to patient compliance and inconsistent efficacy. Given these limitations, there is a compelling need for innovative approaches to improve scar management in clinical settings. This study aimed to systematically evaluate the safety and therapeutic efficacy of a novel pressure-enhanced scar patch designed to address the aforementioned clinical challenges. A rabbit ear hypertrophic scar model was utilized, established through the perichondrium-preservation method, which demonstrated a 100% modeling success rate. The experimental subjects were stratified into pressure-treated and control groups, with multidimensional assessments conducted at 10, 20 and 30 days post-operation to gauge the outcomes. Safety evaluations indicated a cumulative irritation index of 0.33 from skin irritation tests (score < 0.5), confirming non-irritancy. Infrared thermal imaging revealed no significant alterations in skin temperature compared to baseline (P > 0.05), affirming that local blood supply remained unaffected. Histological examinations, including Hematoxylin and Eosin (HE) and PTAH staining, corroborated the absence of epidermal damage, tissue edema, and inflammatory cell infiltration. Efficacy assessments showed a significant reduction in the scar elevation index (SEI) from 3.5 ± 0.31 at day 10 to 1.9 ± 0.44 at day 30 in the treatment group, alongside marked declines in microvessel density (MVD) and collagen volume fraction (CVF), with all parameters achieving statistical significance (P < 0.05). The findings of this study substantiate the high safety profile and significant therapeutic efficacy of the pressure-enhanced scar patch. It effectively mitigates scar pathology by inhibiting fibroblast activation, reducing angiogenesis, and collagen deposition while promoting the reconstruction of elastic fibers. These results provide a reliable foundation for the clinical management of hypertrophic scars and pave the way for further research into optimized scar treatment strategies.