Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings

Postoperative formation of adhesions, scarring, synechiae, ostial stenosis and edema are major concerns often addressed by the placement of bioresorbable packing intraoperatively. Bioresorbable packing has been demonstrated to decrease the incidence of adhesions and bleeding while improving patient comfort compared to no packing at all. However, bioresorbable nasal dressings oftentimes have not dissolved by the time of the first postoperative debridement 1-2 weeks after the surgery and therefore need to be removed. The removal of bioresorbable packing during postoperative debridements is usually an uncomfortable experience for the patient. An ideal nasal dressing would optimize both patient comfort as well as wound healing.

This is a prospective randomized controlled multicenter study at the University of Southern California and Northwestern University that will enroll at least 30 participants who satisfy criteria to compare the efficacy of PuraSinus versus standard of care in patients undergoing endoscopic sinus surgery. The study will utilize an intra-patient control design to assess the safety and efficacy of PuraSinus compared to bioresorbable packing on the contralateral side. The study patients will undergo PuraSinus placement in one nasal cavity following traditional endoscopic sinus surgery. The study is blinded, meaning that patients will be blinded throughout the study duration to which side received PuraSinus placement. The independent surgeon performing review of the video-endoscopies will also be blinded to which side received PuraSinus.

The patient will undergo follow-up assessments including endoscopic examination at three (3) post-operative visits at week 1, week 4, and week 12. A postoperative endoscopic debridement of the ethmoid cavities will be performed bilaterally at week 1. Primary and secondary outcomes will be assessed during the postoperative visits.

Inclusion criteria

• Patient is 18 years of age or older
• Patient has a clinical indication for and has consented for primary or revision bilateral ESS and had evidence of ethmoid disease bilaterally (Lund-Mackay score at least 1 on each side).
• Diagnosed with CRS based on American Academy of Otolaryngology - Head and Neck Surgery guidelines

Exclusion criteria

• Patient has a known history of immune deficiency such as immunoglobulin G or A subclass deficiency, or Human Immunodeficiency Virus (HIV).
• Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g. cancer, HIV, etc.)
• Patient has clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90 day followup period.
• Patient is currently participating in another clinical trial.
• Patient has a known coagulation disorder.
• Patient is allergic to shellfish.