ADVANCE: a multisite trial of bioabsorbable steroid-eluting sinus implants.

摘要: Objectives/Hypothesis: Disease recurrence and adverse wound healing in the form of inflammation, polyposis, adhesions, middle turbinate lateralization may induce suboptimal outcomes following sinus surgery. The study objective was to assess safety effectiveness a bioabsorbable, steroid-eluting implant used functional endoscopic surgery patients with chronic rhinosinusitis (CRS). Study Design: Prospective, multicenter, single-cohort trial enrolling 50 patients. Methods: The allowed bilateral or unilateral placement. Oral topical steroids were withheld for 60 days postoperatively. Endoscopic follow-up performed days. Patient-reported (Sino-Nasal Outcome Test-22 Questionnaire, Rhinosinusitis Disability Index) collected 6 months. Efficacy assessed by grading polyp formation, position. Safety assessment included ocular exams at baseline 30 days. Results: Implants successfully placed all 90 sinuses. Mean inflammation scores minimal time points. At 1 month, prevalence polypoid edema 10.0%, significant adhesions 1.1%, 4.4%. Changes from patient-reported statistically (P < .0001). No clinically changes intraocular pressure occurred. Conclusions: This consecutive case series provides clinical evidence safety, effectiveness, utility bioabsorbable use CRS patients. associated favorable rates patency. degrees observed, suggesting positive impact local steroid delivery without risk. Laryngoscope, 121:2473-2480, 2011