Prospective, randomized, controlled clinical trial of a novel matrix hemostatic sealant in patients with acute anterior epistaxis.

摘要

OBJECTIVES: Floseal, a novel hemostatic sealant composed of collagen-derived particles and topical bovine-derived thrombin, is applied as a high-viscosity gel for hemostasis. This study is a prospective, randomized, controlled clinical trial of Floseal compared with nasal packing in patients with acute anterior epistaxis. STUDY DESIGN: Institutional review board-approved, prospective, randomized, controlled, nonblinded, crossover clinical trial. METHODS: Seventy consecutive patients presenting with acute anterior epistaxis were randomized to receive Floseal or nasal packing for control. Patients were crossed over to the other technique after two unsuccessful attempts of the first technique. Patients were seen in the clinic within 7 days for follow-up. Ten-point visual analogue scales were used to rank effectiveness (1 = ineffective, 10 = effective), physician technical ease (1 = difficult, 10 = easy), physician satisfaction (1 = unsatisfied, 10 = satisfied), patient discomfort during hemostasis (0 = none, 9 = unbearable), patient discomfort at follow-up office visit, and patient satisfaction. Additional data included need for subspecialist consultation to control bleeding, rebleeding rates within 7 days, and rebleeding at follow-up visit. RESULTS: Floseal (n = 35) was judged by physicians to be more effective than nasal packing (n = 35) at initial control of anterior epistaxis (9.9 vs. 7.7, P < .001). Physicians found Floseal to be easier to use (9.4 vs. 3.2, P < .001) and were more satisfied with Floseal (9.6 vs. 3.5, P < .001). Patients experienced less discomfort with Floseal than with nasal packing both at initial control (1.4 vs. 8.9, P < .001) and at follow-up visit (0.0 vs. 8.5, P < .001), and Floseal patients were more satisfied overall (9.1 vs. 2.9, P < .001). Fewer in-person otolaryngology consultations were requested for Floseal patients (8.6% vs. 31.0%, P < .05). Floseal patients experienced fewer rebleeding rates within 7 days (14% vs. 40%, P < .05). Rebleeding rates at follow-up visit were higher in the nasal packing than the Floseal group at time of packing removal (63% vs. 0%, P < .001). Eight (23%) patients were crossed over from the nasal packing group to the Floseal group when nasal packing was ineffective. One Floseal patient (3%, P < .05) was crossed over into the nasal packing group. There were no complications in either group. CONCLUSIONS: Floseal hemostatic sealant is a better tolerated, more effective, safe, and easy alternative to nasal packing in patients presenting with acute anterior epistaxis. Future studies may wish to evaluate Floseal's use in posterior epistaxis.