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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01024075
Recruitment Status : Unknown
Verified December 2009 by University of Calgary.
Recruitment status was:  Recruiting
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
Sponsor:
Information provided by:
University of Calgary

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

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis Drug: Dexamethasone Drug: Saline Phase 4

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Adjunctive Use of a Dexamethasone-Sinufoam Mixture on Endoscopic Sinus Surgery Outcomes: A Randomized, Double-Blind, Placebo-controlled Trial
Study Start Date : November 2009
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Saline
Sinufoam is mixed with saline and placed within the ethmoid cavity at the completion of sinus surgery
 Drug: Saline
8cc of Saline mixed with Sinufoam
Active Comparator: Dexamethasone
Sinufoam is mixed with dexamethasone and placed within the ethmoid cavity at the completion of sinus surgery
 Drug: Dexamethasone
4cc of Dexamethasone and 4cc of Saline mixed with Sinufoam


Outcome Measures
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Primary Outcome Measures :
  1. Sinonasal mucosal healing [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Sinonasal quality of life (SNOT-22) [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024075


Contacts
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Contact: Luke Rudmik, MD 403-212-8223 ext 05851 Lukerudmik@hotmail.com

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Luke Rudmik, MD    403-212-8223 ext 05851      
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Luke Rudmik, MD University of Calgary
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Luke Rudmik, MD, University of Calgary
ClinicalTrials.gov Identifier: NCT01024075    
Other Study ID Numbers: 22476
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009
Keywords provided by University of Calgary:
Chronic Rhinosinusitis
Endoscopic sinus surgery
Sinufoam
 Dexamethasone
For patients with Chronic Rhinosinusitis without nasal polyps
Focus: Define the postoperative sinonasal mucosal healing status of 2 Sinufoam mixtures
Additional relevant MeSH terms:
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Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents