title: Effect of a dexamethasone Sinu-Foam™ middle meatal spacer on endoscopic sinus surgery outcomes: a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Off-label drug eluting middle-meatal spacers have shown promising results for improving clinical outcomes following endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS). This study evaluates a dexamethasone Sinu-Foam™ spacer following ESS for CRS without nasal polyposis (CRSsNP).
  
  
  METHODS
  Patients with CRSsNP (n = 36) were enrolled into a double-blind, placebo-controlled trial and randomized into either a treatment arm (dexamethasone Sinu-Foam™ mixture; n = 18) or placebo arm (Sinu-Foam™ alone; n = 18). Therapeutic outcomes were evaluated at 1 week, 4 weeks, and 3 months using sinonasal endoscopy and graded using the Lund-Kennedy scoring system. Postoperative care included nasal saline irrigations and a short course of systemic steroids.
  
  
  RESULTS
  All patients completed the study follow-up period. Both study arms experienced significant improvement in endoscopic grading over the study duration (p < 0.001). There was no difference in average endoscopic scores between the treatment and placebo groups at 1 week, 4 weeks, and 3 months (all p > 0.489).
  
  
  CONCLUSIONS
  This study demonstrated that an off-label drug-eluting middle-meatal spacer of dexamethasone and Sinu-Foam™ does not improve endoscopic outcomes in the early postoperative period following ESS when combined with postoperative saline irrigations and a short course of systemic steroids.
authors.affiliation: Division of Rhinology and Sinus Surgery, Calgary Sinus Center, Department of Otolaryngology-Head and Neck Surgery, University of Calgary, Alberta, Canada. Lukerudmik@gmail.com
authors.forename: Luke
authors.initials: L
authors.lastname: Rudmik
authors.forename: Jess
authors.initials: J
authors.lastname: Mace
authors.forename: Brad
authors.initials: B
authors.lastname: Mechor
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D003907:Dexamethasone / Q000008:administration & dosage*; D004311:Double-Blind Method; D004724:Endoscopy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D010256:Paranasal Sinuses / Q000601:surgery*; D011446:Prospective Studies; D012220:Rhinitis / Q000601:surgery*; D012852:Sinusitis / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D003907:Dexamethasone