The efficacy of a novel budesonide chitosan gel on wound healing following endoscopic sinus surgery

Background

Adhesion formation and ostial stenosis are common causes of surgical failure after endoscopic sinus surgery (ESS). Postoperative topical steroid application has been shown to improve wound healing. Chitosan-dextran gel (CD gel) is an effective hemostatic nasal dressing. This study aims to determine the effect of the addition of budesonide to CD gel on postoperative ostial stenosis and adhesion formation following ESS.

Methods

This prospective, blinded, randomized controlled trial was conducted between October 2012 and April 2015. Thirty-six patients over 18 years undergoing ESS were randomized to receive either: no treatment, CD gel, CD gel with 1 mg/ 2 mL budesonide, or topical steroid cream to their left or right sinuses (different treatment each side). Each sinus ostium and endoscopic features of wound healing was measured intraoperation, and 2 weeks, 3 months, and 12 months postoperation.

Results

Data was analyzed using the analysis of variance (ANOVA) and post hoc Tukey honestly significant difference (HSD) tests. There was a significant reduction in stenosis within all 3 sinuses ostia sites when CD + budesonide was compared to control, with the greatest effect seen at 12 months: The mean ± standard deviation (SD) percentage of baseline areas at 12 months were 76% ± 6.2% vs 37% ± 23.5%, 76% ± 6.3% vs 52% ± 4.9%, and 83% ± 6.5% vs 58% ± 5.0% (all p < 0.05), for CD + budesonide compared to control in the frontal, sphenoid, and maxillary sinuses, respectively. The incidence of adhesions was 4% in the CD + budesonide group compared to 15% in the control group.

Conclusion

This study has shown that CD gel, when combined with topical budesonide solution, improves long-term sinus ostial patency and prevents ostial stenosis post-ESS.

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