A Prospective Study on the Safety and Effectiveness of a Composite Sinus Stent for Use After Endoscopic Sinus Surgery.

Background The composite sinus stent was developed to support the nasal walls, stabilize the middle turbinate, and prevent adhesions following endoscopic sinus surgery (ESS). Objective This study sought to assess its safety and effectiveness. Methods A prospective clinical trial was conducted in a single medical center in 2016-2018. The study included 30 patients (64% males) with a mean age of 41.9 years, who were scheduled for bilateral ESS, were randomized to undergo composite sinus stent implantation for 14 to 28 days or middle meatus placement of a Telfa tampon for 2 to 3 days. Telfa is a nonadherent absorbent dressing that has been compared favorably with other packs for use following ESS. Both groups received the same postoperative treatment. Outcomes were evaluated endoscopically by the principal investigator and also by an independent investigator blinded to the intervention the patient had and by self-report questionnaires at 3 and 12 weeks postoperatively. Results The stent was successfully implanted and removed in all 29 treated sinuses, without complications. None of the stents showed granulation tissue or crusting. Compared to the tampon group, the stent group had significantly less inflammation (mean visual analog scale scores 0.2 vs 4.2 at 12 weeks, P = .01). The probability of having adhesion was 9.3 times greater in the control group compared to the study group (P = .026), and middle turbinate lateralization rate at 12 weeks was 3.8% versus 44% in the study group and the control group, respectively, at 12 weeks (P = .006). Patients who underwent stent implantation experienced higher symptomatic improvement (Sino-Nasal Outcome Test 22 of -37.13 vs -28.07, P = .01, in study and control groups, respectively). During stent implantation (2-4 weeks), patients did not suffer from any discomfort. Conclusions The composite sinus stent is safer and more effective than the Telfa tampon in maintaining sinus cavity patency and promoting healing following ESS.