Safety and effectiveness of a drug-loaded haemostatic sponge in chronic rhinosinusitis:A randomized, controlled, double-blind study

Abstract

Abstract The aim of this study was to investigate the safety and efficacy of a novel drug-loaded haemostatic sponge (DLHS) in the sinus. In this clinical trial, 49 patients were randomly divided into 2 groups: group A (n = 25) had the DLHS placed into the sinus, and group B (n = 24) had the Nasopore placed after Endoscopic sinus surgery (ESS). Endoscopic follow-up was performed for 12 weeks, and the findings were classified using the discharge, inflammation, polyps/oedema (DIP) endoscopic appearance scores. All patients completed questionnaires to evaluate their sinonasal symptoms by using the sinonasal outcome test-22 (SNOT-22) and visual analogue scale (VAS). Serum cortisol concentration in group A was measured prior to surgery and at days 1, 3, 7, and 14 after nasal surgery. Comparing group A and group B, at 2 weeks, no significant differences were observed in either objective or subjective parameters. The mean value of VAS for rhinorrhoea and DIP for oedema and the mean value of nasal adhesion appeared to be significantly lower in Group A than in Group B at 6 and 12 weeks, but a significant difference did not occur in SNOT-22 and VAS for dysosmia between the two groups at 6 and 12 weeks. The mean serum cortisol concentrations in group A at the follow-up were within normal limits without remarkable fluctuations. This study demonstrates the safety and efficacy of the DLHS with the possibility of being used in CRS patients.