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

Area of Science:

• Otolaryngology
• Rhinology
• Biomaterials Science

Background:

• Chronic rhinosinusitis (CRS) surgery can lead to recurrence and poor healing.
• Complications include inflammation, polyposis, adhesions, and middle turbinate lateralization.
• A novel bioabsorbable, steroid-eluting implant aims to mitigate these issues.

Purpose of the Study:

• To evaluate the safety and effectiveness of a steroid-eluting implant post-functional endoscopic sinus surgery (FESS) in CRS patients.
• To assess the implant's impact on wound healing and disease recurrence.
• To determine the clinical utility of local steroid delivery via implant.

Main Methods:

• Prospective, multicenter, single-cohort trial with 50 CRS patients.
• Bilateral or unilateral steroid-eluting implant placement.
• Exclusion of oral/topical steroids for 60 days; follow-up to 6 months for patient-reported outcomes and 60 days for endoscopic assessment.

Main Results:

• Successful implant placement in all 90 sinuses.
• Minimal mean inflammation scores throughout the study.
• Low prevalence of polyposis (10.0%), adhesions (1.1%), and middle turbinate lateralization (4.4%) at 1 month.
• Statistically significant improvements in patient-reported outcomes (P < .0001).
• No clinically significant ocular pressure changes.

Conclusions:

• The bioabsorbable steroid-eluting implant is safe and effective for CRS patients undergoing FESS.
• Favorable sinus patency rates were observed.
• Minimal inflammation and adhesions suggest positive clinical impact from local steroid delivery.
• No ocular risks were identified, supporting the implant's clinical utility.