Steroid Delivery to the Frontal Sinus Opening With a Bioabsorbable Implant vs. a Bioabsorbable Nasal Dressing

This is a single center, randomized & controlled trial comparing the efficacy of the Propel
mini stent or Propel contour stent vs. Nasopore impregnated with Triamcinolone Acetonide at
reducing frontal sinus opening stenosis and polypoid edema after endoscopic sinus surgery in
patients with chronic rhinosinusitis with polyposis. Eligible subjects who undergo standard
of care bilateral frontal sinusotomy will have each frontal sinus randomly assigned to either
a Propel mini or contour steroid eluding stent or a Nasopore nasal dressing impregnated with
2.5 ml of Triamcinolone Acetonide 40 mg/ml. Specific Propel stent will be chosen based on the
shape of frontal sinus opening and best fit as decided by the operating Surgeon. Patients
will be reassessed on approximately post-operative day 7, 14, 30, 90 days, 6 months, and 12
months at their standard of care follow-up visits. On the day 14 visit, the frontal sinus
Propel stent and Nasopore will be completely removed per Standard of care. Video will be
taken of the frontal sinus opening, and assessed for scarring/adhesions, presence of polypoid
edema, frontal sinus patency, need for oral steroids or other interventions. Additionally,
endoscopic scoring of frontal sinus by the above measures will be evaluated by 2 independent
sinus surgeon reviewers. The reviewers will also be asked to rank the two frontal sinus
openings as better, same or worse, compared to the opposite side

Inclusion Criteria:

- Adults aged 18 and older

- Diagnosis of chronic rhinosinusitis with nasal polyps based on the American Academy of
Otolaryngology-Head and Neck Surgery guidelines

- Patient scheduled for bilateral endoscopic sinus surgery with evidence of bilateral
frontal sinus disease based on Computed Tomography (Lund-Mackay score greater than or
equal to 1)

- At the time of surgery bilateral frontal sinusotomy of type Draf 2a or 2b was
performed using the same technique on both sides

- Bilateral endoscopic sinus surgery performed successfully without complication

- Frontal sinus opening diameter greater than 4.0 mm achieved (4 mm olive tipped suction
easily passed into frontal sinus)

Exclusion Criteria:

- Any patient who had frontal sinus surgery for tumor

- Allergy to mometesone and/or triamcinolone

- Frontal sinusotomy type Draf 1 or Draf 3 performed

- One or both frontal sinus openings not amenable to implant placement

- Patients with chronic oral steroid dependent conditions

- Invasive fungal sinusitis

- Immune deficiency