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Effect of Sinufoam-Dexamethasone Mixture on Post Endoscopic Sinus Surgery Outcomes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Calgary.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT01024075
First received: November 30, 2009
Last updated: December 1, 2009
Last verified: December 2009

November 30, 2009
December 1, 2009
November 2009
November 2010   (final data collection date for primary outcome measure)
Sinonasal mucosal healing [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01024075 on ClinicalTrials.gov Archive Site
Sinonasal quality of life (SNOT-22) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Sinufoam-Dexamethasone Mixture on Post Endoscopic Sinus Surgery Outcomes
The Adjunctive Use of a Dexamethasone-Sinufoam Mixture on Endoscopic Sinus Surgery Outcomes: A Randomized, Double-Blind, Placebo-controlled Trial

Dexamethasone added to sinufoam, which is placed in the ethmoid cavity at the completion of endoscopic sinus surgery, will improve sinonasal mucosal healing.

Sinufoam is an FDA approved mixture, which is placed in the ethmoid cavity at the completion of an endoscopic sinus surgery procedure. Sinufoam prevents scarring and promotes healing of the sinonasal mucosa. Sinufoam is commonly mixed with saline, which enables it to be liquefied and gently placed into the ethmoid cavity. Recent practice of adding Dexamethasone to the sinufoam mixture has been hypothesized to promote healing by reducing chronic inflammation associated with CRS. Using topical dexamethasone mixed into the Sinufoam solution may improve patient care by preventing the systemic effects associated with post-operative systemic steroid use.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Rhinosinusitis
  • Drug: Dexamethasone
    4cc of Dexamethasone and 4cc of Saline mixed with Sinufoam
  • Drug: Saline
    8cc of Saline mixed with Sinufoam
  • Placebo Comparator: Saline
    Sinufoam is mixed with saline and placed within the ethmoid cavity at the completion of sinus surgery
    Intervention: Drug: Saline
  • Active Comparator: Dexamethasone
    Sinufoam is mixed with dexamethasone and placed within the ethmoid cavity at the completion of sinus surgery
    Intervention: Drug: Dexamethasone
Rudmik L, Mace J, Mechor B. Effect of a dexamethasone Sinu-Foam™ middle meatal spacer on endoscopic sinus surgery outcomes: a randomized, double-blind, placebo-controlled trial. Int Forum Allergy Rhinol. 2012 May-Jun;2(3):248-51. doi: 10.1002/alr.21011. Epub 2012 Jan 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
May 2011
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age >18 years old
  • Chronic Rhinosinusitis without nasal polyps --- defined according to the AAO guidelines
  • Elective "Bilateral" sinus surgery requiring at a minimum of an Uncinectomy, Maxillary Antrostomy, and Anterior Ethmoidectomy.

Exclusion Criteria:

  • Uncorrectable coagulopathy
  • Emergency procedure
  • Unavailable for standard post operative follow-up
  • Sinonasal neoplasm resections
  • Excessive intra-operative bleeding requiring nasal packing
Both
18 Years and older
No
Contact: Luke Rudmik, MD 403-212-8223 ext 05851 Lukerudmik@hotmail.com
Canada
 
NCT01024075
22476
No
Luke Rudmik, MD, University of Calgary
University of Calgary
Not Provided
Principal Investigator: Luke Rudmik, MD University of Calgary
University of Calgary
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP