Amulti site trial of bioabsorbable steroid-eluting sinus implants

Historically, in many multi-site studies, each site has its own IRB which conducts an independent review of studies involving human research participants. The use of a single IRB of record for multi-site studies that are conducting the same protocol will help streamline the IRB review process by eliminating the unnecessary repetition of those reviews across sites.

The goal of this policy is to enhance and streamline the IRB review process for multi-site research so that research can proceed as quickly as possible without compromising ethical principles and protections for human research participants.

AB - Objectives/Hypothesis: Disease recurrence and adverse wound healing in the form of inflammation, polyposis, adhesions, and middle turbinate lateralization may induce suboptimal outcomes following sinus surgery. The study objective was to assess the safety and effectiveness of a bioabsorbable, steroid-eluting implant used following functional endoscopic sinus surgery in patients with chronic rhinosinusitis (CRS). Study Design: Prospective, multicenter, single-cohort trial enrolling 50 patients. Methods: The study allowed bilateral or unilateral steroid-eluting implant placement. Oral and topical steroids were withheld for 60 days postoperatively. Endoscopic follow-up was performed to 60 days. Patient-reported outcomes (Sino-Nasal Outcome Test-22 Questionnaire, Rhinosinusitis Disability Index) were collected to 6 months. Efficacy was assessed by grading inflammation, polyp formation, adhesions, and middle turbinate position. Safety assessment included ocular exams at baseline and 30 days. Results: Implants were successfully placed in all 90 sinuses. Mean inflammation scores were minimal at all time points. At 1 month, the prevalence of polypoid edema was %, significant adhesions %, and middle turbinate lateralization %. Changes from baseline in patient-reported outcomes were statistically significant (P

Amulti site trial of bioabsorbable steroid-eluting sinus implants

a multi site trial of bioabsorbable steroid-eluting sinus implants

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