A randomized controlled pilot study of epsilon-aminocaproic acid as a topical hemostatic agent for postoperative bleeding in the sheep model of chronic sinusitis

Abstract

<h4>Background</h4>Significant bleeding with blood clot formation in the postoperative period may predispose to the formation of postoperative adhesions. A topical hemostatic agent would potentially improve postoperative comfort and lessen adhesion formation. This pilot study was performed to evaluate the effects of a novel topical hemostatic agent AMICAR (epsilon-aminocaproic acid; Xanodyne Pharmacal, Inc., Florence, KY) on postoperative bleeding after endoscopic sinus surgery (ESS).<h4>Methods</h4>In a prospective randomized controlled pilot study full thickness mucosal injuries were created on the lateral nasal wall, ethmoturbinal and the maxillary ostium on both sides of 10 sheep. Eosinophilic chronic sinusitis was confirmed both by endoscopy and by biopsy before full thickness injuries. The topical hemostatic agent (AMICAR) was sprayed onto a randomly selected side with or without mucoadhesive methyl cellulose (5 sheep in each group). The control side received a spray of saline of equal volume. The degree of bleeding in the surgical field was graded using a visual analog scale until total hemostasis was achieved. The grades at 2-minute intervals as well as the time to achieve total hemostasis were recorded.<h4>Results</h4>Eosinophilia of the epithelium did not correlate with the severity of bleeding (p<0.05). There was a statistically significant reduction in the grade of bleeding in the lateral nasal wall both superior and inferior to the middle turbinate attachment when AMICAR alone was used compared with normal saline (p=0.004 and p=0.003, respectively) but when AMICAR was used in combination with methyl cellulose this significance was lost (p=0.076 and p=0.502).<h4>Conclusion</h4>AMICAR may be considered for use either during or after sinus surgery to reduce bleeding.