A blinded randomized controlled trial evaluating the efficacy of chitosan gel on ostial stenosis following endoscopic sinus surgery

Background: Stenosis of sinus ostia following endoscopic sinus surgery (ESS) is the most common reason for revision surgery. Chitosan-dextran (CD) gel has been shown to be an effective hemostatic agent; however, its effects on ostial stenosis are unknown. This study aims to quantify the effect of CD gel on circumferential scarring following ESS. Methods: A prospective, blinded, randomized, controlled trial was conducted in 26 patients undergoing ESS. Measurements of neo-ostia were taken using a standard-sized measuring probe. CD gel was applied unilaterally, while contralateral sides received no gel. Ostial diameters were measured by a blinded observer at 2, 8, and 12 weeks postoperation. Sinus ostial areas calculated as a proportion of the original were compared for each ostium at each time point. Results: Intraoperative ostial areas were comparable for CD gel and control sides (38 mm² vs 39 mm², 131 mm² vs 120 mm², and 203 mm² vs 193 mm², in frontal, sphenoid, and maxillary ostia, respectively; p > 0.05). CD gel significantly improved sinus ostial patency. The largest difference was seen when ostial areas at 12 weeks were compared with their corresponding baseline areas (66% vs 31% frontal, p < 0.001; 85% vs 47% sphenoid, p < 0.001; and 74% vs 54% maxillary ostia, p = 0.002). The difference between raw ostial areas reached statistical significance in sphenoid (p < 0.001) and maxillary (p = 0.01), but not in frontal ostia (p > 0.05) at 12 weeks. Conclusion: CD gel produced significantly less stenosis of all neo-ostia following ESS and may reduce the necessity for revision surgery in patients with chronic rhinosinusitis.