Clinical Research Directory

Efficacy of Early Postoperative ON101 Application for Lower-extremity Fracture Incisions: a Prospective Evaluator-blinded Controlled Study of Scar Quality and Digital-clinical Concordance

Sponsor: LIN Kai-Cheng

Summary

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.

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