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

Primary Purpose

Chronic Rhinosinusitis

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Dexamethasone
Saline
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Saline

Dexamethasone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Sinonasal mucosal healing

Secondary Outcome Measures

Sinonasal quality of life (SNOT-22)

Full Information

First Posted
November 30, 2009
Last Updated
December 1, 2009
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT01024075
Brief Title
Effect of Sinufoam-Dexamethasone Mixture on Post Endoscopic Sinus Surgery Outcomes
Official Title
The Adjunctive Use of a Dexamethasone-Sinufoam Mixture on Endoscopic Sinus Surgery Outcomes: A Randomized, Double-Blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Sinufoam is mixed with saline and placed within the ethmoid cavity at the completion of sinus surgery
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Sinufoam is mixed with dexamethasone and placed within the ethmoid cavity at the completion of sinus surgery
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
4cc of Dexamethasone and 4cc of Saline mixed with Sinufoam
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
8cc of Saline mixed with Sinufoam
Primary Outcome Measure Information:
Title
Sinonasal mucosal healing
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Sinonasal quality of life (SNOT-22)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luke Rudmik, MD
Phone
403-212-8223
Ext
05851
Email
Lukerudmik@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luke Rudmik, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luke Rudmik, MD
Phone
403-212-8223
Ext
05851

12. IPD Sharing Statement

Citations:
PubMed Identifier
22253199
Citation
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.
Results Reference
derived

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

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