Recruiting

Sinufoam-Dexamethasone

Sponsor:

University of Calgary

Code:

NCT01024075

Conditions

Chronic Rhinosinusitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

Saline

Study Details

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.

Conditions

Chronic Rhinosinusitis

Study ID

NCT01024075

Start date

Nov, 2009

Status verified date

Dec, 2009

Completion date

May, 2011

Anticipated

Primary completion date

Nov, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Saline

Sinufoam is mixed with saline and placed within the ethmoid cavity at the completion of sinus surgery

active comparator: Dexamethasone

Sinufoam is mixed with dexamethasone and placed within the ethmoid cavity at the completion of sinus surgery

Interventions

Dexamethasone

4cc of Dexamethasone and 4cc of Saline mixed with Sinufoam

Saline

8cc of Saline mixed with Sinufoam

Primary outcome measure

  • Sinonasal mucosal healing [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Luke Rudmik, MD

403-212-8223Lukerudmik@hotmail.com

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Luke Rudmik, MD

403-212-8223

More Information

Sponsor

University of Calgary

Last update posted

Dec 2, 2009

Last verified

Dec, 2009

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2009-12-02.