NCT01024075

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

December 2, 2009

Status Verified

December 1, 2009

Enrollment Period

1 year

First QC Date

November 30, 2009

Last Update Submit

December 1, 2009

Conditions

Chronic Rhinosinusitis

Keywords

Chronic RhinosinusitisEndoscopic sinus surgerySinufoamDexamethasoneFor patients with Chronic Rhinosinusitis without nasal polypsFocus: Define the postoperative sinonasal mucosal healing status of 2 Sinufoam mixtures

Outcome Measures

Primary Outcomes (1)

  • Sinonasal mucosal healing

    1 month

Secondary Outcomes (1)

  • Sinonasal quality of life (SNOT-22)

    1 month

Study Arms (2)

Saline

PLACEBO COMPARATOR

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

Drug: Saline

Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

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

Dexamethasone
SalineDRUG

8cc of Saline mixed with Sinufoam

Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Uncorrectable coagulopathy
  • Emergency procedure
  • Unavailable for standard post operative follow-up
  • Sinonasal neoplasm resections
  • Excessive intra-operative bleeding requiring nasal packing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22253199DERIVED

MeSH Terms

Interventions

DexamethasoneSodium Chloride

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Luke Rudmik, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luke Rudmik, MD

CONTACT

403-212-8223Lukerudmik@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 2, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2010

Study Completion

May 1, 2011

Last Updated

December 2, 2009

Record last verified: 2009-12

Locations

CA(1)