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Effect of a dexamethasone Sinu‐Foam TM middle meatal spacer on endoscopic sinus surgery outcomes: A randomized, double‐blind, placebo‐controlled trial
Author(s) -
Rudmik Luke,
Mace Jess,
Mechor Brad
Publication year - 2012
Publication title -
international forum of allergy and rhinology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.503
H-Index - 46
eISSN - 2042-6984
pISSN - 2042-6976
DOI - 10.1002/alr.21011
Subject(s) - medicine , placebo , dexamethasone , surgery , randomized controlled trial , saline , functional endoscopic sinus surgery , endoscopic sinus surgery , clinical trial , endoscopy , sinusitis , anesthesia , alternative medicine , pathology
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 TM 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 TM mixture; n = 18) or placebo arm (Sinu‐Foam TM 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). Conclusion: This study demonstrated that an off‐label drug‐eluting middle‐meatal spacer of dexamethasone and Sinu‐Foam TM 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. © 2011 ARS‐AAOA, LLC.