Real-World Evaluation of the Safety and Efficacy of Surgi-ORC® in Orthopedic Surgeries: A Multicenter Prospective Study.

Aim Achieving adequate hemostasis is a critical aspect of surgical practice, especially in orthopedics, where bleeding can impact visibility and patient outcomes. Surgi-ORC® (Aegis Lifesciences Pvt. Ltd., Ahmedabad, India), an oxidized regenerated cellulose hemostatic agent, was evaluated for its safety, efficacy, biocompatibility, and clinical performance in real-world patients undergoing orthopedic surgeries. Method This prospective observational study included patients undergoing upper limb, lower limb, or axial skeletal orthopedic surgeries. Blood loss, time to hemostasis (TTH), and surgeon-rated performance parameters such as ease of application, conformation to tissue, and preparation were recorded to assess the performance of Surgi-ORC® at predefined time points. Biocompatibility assessments were conducted through in vitro and in vivo tests, including reactivity, sensitization, systemic toxicity, tissue response, and hemolytic potential. Results The study involved 59 patients undergoing orthopedic surgeries using Surgi-ORC® variants: Powder (n=4), Knit (n=5), Original/Standard (n=4), Fibril (n=42), and Non-Woven/Snow (n=4). Hemostasis was achieved in 100% of cases within ≤ five minutes, with a mean TTH of 1.95 minutes (Surgi-ORC® Original/Standard). Powder demonstrated the lowest mean TTH across all surgeries, averaging 0.83 to 1.08 minutes. Surgeon feedback highlighted excellent handling, ease of application, and conformance to tissue without sticking/adherence to surgical gloves/surgical instruments. No infections, adverse events, or complications occurred over 60 days, and all patients showed stable recoveries. The surgeon confirmed complete absorption by day two.  Conclusion Surgi-ORC® is a reliable and effective hemostatic agent for orthopedic surgeries. Its ease of use, handling characteristics, ease of placing, stability upon placement, and safety profile make it a preferred choice among surgeons.