A total of 35 patients with chronic rhinosinusitis (CRS) who were undergoing sinus surgery were included in the phase 1 part of the study. Each patient had a MeroGel stent placed in the middle meatus on the right, and a Nasopore square in the middle meatus on the left. Each patient also received one week of postoperative oral antibiotics, a Depo-Medrol injection in recovery, and nasal irrigations for a month at follow-up visits.
Explore This IssueAugust 2008
There were 69 patients in the phase 2 portion of the study. Here, plain Nasopore was used in the left middle meatus, and for the right side, the foam was soaked in a Bacitracin solution of 50 mg/cc. Patients underwent the same postoperative regimen but had two fewer days of oral antibiotics. Endoscopy was performed postsurgery to evaluate the middle meatus at two, six, and 12 weeks.
At the end of phase 1, researchers found no real differences between the two groups of patients. Nasal congestion in almost every patient was normal up to two weeks. Headaches were again pretty equal and normal postoperatively. The infection was higher in the MeroGel side than the Nasopore side, but nothing that was of significance, Dr. Catalano said. The stents had all dissolved by a 14-day postsurgery follow-up visit.
As for results from phase 2, there were only minor differences found between patients who received the pharmacologically active stents and those who received the plain ones. On the Bacitracin side versus the plain side, there was absolutely no evidence of any kind of biological reactivity, he said.
Phase 3 is under way and will prospectively evaluate Nasopore for local drug delivery in a randomized controlled trial without systemic antibiotic coverage. The overall goal is to minimize or eliminate the need for systemic medications and their associated side effects and costs, he said.
However, Dr. Catalano noted there were some limitations to the study and that more research needs to be done. This was essentially a feasibility study.
This study is limited by its sample size and the lack of a control group. For the study to be powered properly to show a statistical significance, we’d have to have about 700 patients, due to the relatively low incidence of postoperative sinusitis in this population. It does, however, represent an important first step in attempting to provide local drug delivery for patients undergoing endoscopic sinus surgery, he said.
©2008 The Triological Society