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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
  Purpose

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


Condition Intervention Phase
Chronic Rhinosinusitis
Drug: Dexamethasone
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Sinonasal mucosal healing [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sinonasal quality of life (SNOT-22) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024075

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

Locations
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
Principal Investigator: Luke Rudmik, MD University of Calgary
  More Information

No publications provided by University of Calgary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luke Rudmik, MD, University of Calgary
ClinicalTrials.gov Identifier: NCT01024075     History of Changes
Other Study ID Numbers: 22476
Study First Received: November 30, 2009
Last Updated: December 1, 2009
Health Authority: Canada: Institutional Review Board

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:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014