The effect of topical vancomycin on the recurrent postoperative sinonasal polyposis: a triple-blinded randomized controlled trial

Abstract

Abstract Objective To assess the effect of topical vancomycin on the prevention of recurrent sinonasal polyposis after functional endoscopic sinus surgical procedure. Design, setting, and participants A triple-blind, randomized clinical trial of patients aged 18–70 years with sinonasal polyposis whose nasal swab results were positive for Staphylococcus aureus and were candidates for functional endoscopic sinus surgical procedure at Besat Hospital, Hamadan University of Medical Sciences, from September 2014 to September 2015. Interventions Patients were randomly assigned to receive a solution of normal saline including 1 g/l vancomycin or a solution of normal saline alone (placebo). Patients were asked to irrigate their nose with 20ml of the prepared solution three times a day for 8 weeks. Main outcomes and measure The recurrent polyposis and reinfection with S. aureus at 2, 4, and 6 months after sinus surgery. Results Of 118 patients identified, 35 patients whose nasal swab results were positive for S. aureus remained for analysis, and of those, 18 patients were allocated to the placebo group and 17 to the vancomycin group. There was no statistically significant but clinically important difference in the severity of recurrent postoperative polyposis between the two groups. The recurrence rate of postoperative sinonasal polyposis was clinically different between the two groups, although the difference was not statistically significant. The proportion of reinfection with S. aureus in the second month after surgery was 11/18 (61.1%) in the control group versus 3/17 (17.6%) in the vancomycin group (P=0.015). No significant drug adverse effect was reported by the patients. Conclusion and relevance This trial indicated that topical vancomycin is a safe drug with no important adverse effects that may reduce the recurrent postoperative polyposis. However, more evidence based on large clinical trials is required to justify the efficacy of topical vancomycin for preventing postoperative polyposis.

Keywords

• clinical trial
• endoscopic surgery
• nasal polyps
• vancomycin