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

December 1, 2009 updated by: University of Calgary

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Recruiting
        • University of Calgary
        • Contact:
          • Luke Rudmik, MD
          • Phone Number: 05851 403-212-8223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sinonasal mucosal healing
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Sinonasal quality of life (SNOT-22)
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ANTICIPATED)

November 1, 2010

Study Completion (ANTICIPATED)

May 1, 2011

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (ESTIMATE)

December 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2009

Last Update Submitted That Met QC Criteria

December 1, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22476

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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