Document Detail


Effect of a dexamethasone Sinu-Foam(TM) middle meatal spacer on endoscopic sinus surgery outcomes: A randomized, double-blind, placebo-controlled trial.
MedLine Citation:
PMID:  22253199     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
Luke Rudmik; Jess Mace; Brad Mechor
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-1-17
Journal Detail:
Title:  International forum of allergy & rhinology     Volume:  -     ISSN:  2042-6984     ISO Abbreviation:  -     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2012-1-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101550261     Medline TA:  Int Forum Allergy Rhinol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 American Rhinologic Society-American Academy of Otolaryngic Allergy, LLC.
Affiliation:
Division of Rhinology and Sinus Surgery, Calgary Sinus Center, Department of Otolaryngology-Head and Neck Surgery, University of Calgary, Calgary, Alberta, Canada. Lukerudmik@gmail.com.
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