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

NCT ID: NCT01024075

Last Updated: 2009-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Rhinosinusitis

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Saline

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

8cc of Saline mixed with Sinufoam

Dexamethasone

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

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

Interventions

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Dexamethasone

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

Intervention Type DRUG

Saline

8cc of Saline mixed with Sinufoam

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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University of Calgary

Principal Investigators

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Luke Rudmik, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Luke Rudmik, MD

Role: CONTACT

Phone: 403-212-8223

Email: [email protected]

Facility Contacts

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Luke Rudmik, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 22253199 (View on PubMed)

Other Identifiers

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22476

Identifier Type: -

Identifier Source: org_study_id