Efficacy of early postoperative ON101 application for lower- extremity fracture incisions: a prospective evaluator-blinded controlled study of scar quality and digital-clinical concordance

Abstract Background Postoperative scars after lower-extremity fracture fixation endure high tension, where excessive scarring can restrict periarticular mobility. While the 2002 International Clinical Recommendations on Scar Management emphasize early prevention, conventional silicone products require complete epithelialization before use. Conversely, ON101 is a topical formulation. The formulation helps to maintain the wound moist environment, and the moist wound environment is conducive for wound healing. This profile suggests potential for earlier intervention. We evaluated whether initiating ON101 during the early postoperative repair phase improves subsequent wound healing and scar maturation. Methods This prospective, evaluator-blinded, controlled study enrolled 30 adults undergoing open reduction and internal fixation for lower-extremity fractures. Patients received once-daily topical ON101 (n = 20) or standard care (n = 10), initiated within 3 days postoperatively before complete epithelialization, and continued for 16 weeks. Blinded clinicians assessed scar maturation using the Vancouver Scar Scale (VSS). Standardized photographs were quantitatively analyzed using CIELab color parameters and gray-level co-occurrence matrix (GLCM) texture features. Results All 30 participants completed the 16-week treatment. The ON101 group demonstrated greater improvement in total VSS scores from the initial evaluable assessment to Week 16 than controls (51.22% vs. 15.10%, p < 0.001). ON101 also yielded significantly greater improvements in vascularity (64.98% vs. 28.33%, p < 0.001), pliability (49.35% vs. -2.08%, p = 0.001), and height (44.32% vs. -16.67%, p < 0.001). Objective image analysis detected treatment-associated differences in color and texture by Weeks 2–16, preceding clinical VSS divergence. No treatment-related adverse events or wound complications were observed. Conclusions From our study, early intervention before epithelialization of orthopedic surgical wound for trauma is associated with more favorable scar maturation in both subjective and objective evaluation tools. While establishing robust improvements in early scar morphology, larger randomized trials are warranted to confirm definitive functional benefits. Trial registration ClinicalTrials.gov, NCT07854470. Retrospectively registered and publicly posted on 2 October 2026.