A Prospective, Randomized Controlled Study to Evaluate the Safety and Effectiveness of Knitted and Fibrillar Forms of Oxidized Regenerated Cellulose for Haemostasis in General and Gynaecological Surgeries

Hemorrhage control is especially challenging in procedures involving vascular-rich planes—such as the uterine bed during myomectomy or the liver parenchyma in hepatectomy—where brisk capillary, venous, or small arterial bleeding is difficult to manage using conventional methods alone. Techniques such as ligature, suturing, and electrocautery, while effective in many scenarios, may be either impractical or damaging in confined or delicate tissue environments. In such cases, hemostatic agents have become indispensable adjuncts. These agents not only reduce intraoperative blood loss but also help minimize reliance on systemic hemostatic or transfusion support, thereby enhancing patient safety and recovery. Among these, Oxidized Regenerated Cellulose (ORC) has garnered extensive clinical use due to its biocompatibility, bio absorbability, bactericidal properties, and ease of application. ORC functions through a physical mechanism: upon contact with blood, it swells to form a gelatinous matrix that facilitates platelet aggregation and clot formation. Simultaneously, its low pH (~3) environment creates a bactericidal effect, inhibiting the growth of common pathogens—a significant advantage in abdominal and pelvic surgeries, where contamination risk is often elevated due to proximity to the gastrointestinal or genitourinary tract. ORC product, is designed in multiple variants and commonly two structural variants—Knitted and Fibrillar—are used to suit different surgical needs. Knitted ORC is composed of interwoven fibres, giving it a firm, fabric-like structure that ensures mechanical strength and durability. This makes it particularly suitable for lining large surgical surfaces, reinforcing suture lines, or packing surgical cavities where tissue approximation is required and the material needs to maintain its shape under pressure. In contrast, Fibrillar ORC has a soft, pliable, and multi-layered texture that enables it to be easily torn, shaped, and moulded. It is highly conformable, allowing it to fill irregular anatomical spaces or adhere to complex surfaces—such as the uterosacral ligaments or paracolic gutters—making it ideal for laparoscopic and endoscopic procedures where access is limited.

Rationale: The rationale for this study stems from the growing need for effective, safe, and versatile hemostatic agents in surgical practice, particularly in general, abdominal, and gynecological procedures, where intraoperative bleeding poses significant clinical and economic burdens. Uncontrolled bleeding not only increases morbidity and transfusion requirements but also prolongs operative time, hospital stay, and overall healthcare costs. In complex anatomical sites or minimally invasive surgeries, traditional methods such as suturing or cautery may be impractical or insufficient, underscoring the need for reliable topical hemostatic solutions.