Development of ready-to-use tranexamic acid gauze as a hemostatic material for oral surgery: fabrication, hemostasis, and shelf-life

Abstract Background Postoperative hemorrhage is one of the major complications of oral surgery. Conventional hemostatic methods, such as chair-side preparation of tranexamic acid (TXA)-soaked gauze or TXA mouthwash, often suffer from dosage variability and increased surgical time. This study aimed to develop a ready-to-use TXA gauze and to evaluate its fabrication process, hemostatic efficiency, and shelf-life stability. Methods Gauze samples containing TXA concentrations of 2.5% and 5% (w/v) were fabricated using a freeze-drying technique. Characterization was performed using field emission scanning electron microscope (FESEM) and fourier transform infrared spectroscopy (FTIR). The in vitro blood clotting time (BCT) and plasma recalcification time (PRT) were assessed using independent biological replicates from six healthy volunteers (n = 6). Biocompatibility was assessed via MTT assay on 3T3 fibroblasts. Shelf-life stability was monitored over 180 days under International Conference on Harmonisation (ICH) Zone IV conditions (30 °C/65% RH and 4 °C). Results The morphological and FTIR measurements confirmed that the gauze fibers were effectively coated with TXA. Meanwhile, the TXA impregnation did not significantly impact the gauze’s physical and biological properties. A burst release of the TXA was observed for the first 3 min, ensuring rapid clot stabilization. In vitro coagulation tests showed that the TXA gauze significantly reduced coagulation times, enhancing the hemostatic process. Similar to 5% TXA gauze, 2.5% TXA gauze had biocompatibility and hemostatic effectiveness. This finding shows that a lower dose (2.5% w/v) achieved hemostasis, maximizing cost-effectiveness and lowering drug toxicity. Stability tests over six months at various temperatures confirmed that the TXA gauze maintained its hemostatic efficacy without significant drug degradation. Conclusions The prefabricated TXA gauze is a promising material, especially for patients on anticoagulant therapy, with long-term stability and practical deployment potential in clinical settings.