Chronic RhinosinusitisPhase 4NCT01024075
Effect of Sinufoam-Dexamethasone Mixture on Post Endoscopic Sinus Surgery Outcomes
A Phase 4 study testing Dexamethasone and Saline in people with Chronic Rhinosinusitis, run by University of Calgary at 1 site in Canada.
Trial summary
Dexamethasone added to sinufoam, which is placed in the ethmoid cavity at the completion of endoscopic sinus surgery, will improve sinonasal mucosal healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- Dexamethasone and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Uncorrectable coagulopathy
- Emergency procedure
- Unavailable for standard post operative follow-up
- Sinonasal neoplasm resections
- Excessive intra-operative bleeding requiring nasal packing
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 2T9
Luke Rudmik, MD, 403-212-8223 ext. 05851
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- Dexamethasone, Saline
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
4cc of Dexamethasone and 4cc of Saline mixed with Sinufoam
SalineDrug
8cc of Saline mixed with Sinufoam
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Sinufoam is mixed with saline and placed within the ethmoid cavity at the completion of sinus surgery Receives: Drug: Saline |
| Dexamethasone | Active comparator | Sinufoam is mixed with dexamethasone and placed within the ethmoid cavity at the completion of sinus surgery Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinonasal mucosal healing
Measured: 1 month
Secondary outcomes (1)
Sinonasal quality of life (SNOT-22)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2010 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Investigators
- Luke Rudmik, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024075
- Sponsor's protocol ID
- 22476
- Status last verified
- Dec 2009
- First submitted
- 30 Nov 2009
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22253199
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjunctive Use of a Dexamethasone-Sinufoam Mixture on Endoscopic Sinus Surgery Outcomes: A Randomized, Double-Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01024075
- Acronym / sponsor ID
- 22476
- Conditions
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: SalineSinufoam is mixed with saline and placed within the ethmoid cavity at the completion of sinus surgery |
| Dexamethasone | Active comparator | Drug: DexamethasoneSinufoam is mixed with dexamethasone and placed within the ethmoid cavity at the completion of sinus surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Uncorrectable coagulopathy
- Emergency procedure
- Unavailable for standard post operative follow-up
- Sinonasal neoplasm resections
- Excessive intra-operative bleeding requiring nasal packing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone4cc of Dexamethasone and 4cc of Saline mixed with Sinufoam | Drug | Dexamethasone |
| Saline8cc of Saline mixed with Sinufoam | Drug | Saline |
Primary outcome
Sinonasal mucosal healing
Time frame: 1 month
1 secondary outcome
Sinonasal quality of life (SNOT-22)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2009.
- Derived from this study: PubMed 22253199Rudmik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke Rudmik, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Saline in people with Chronic Rhinosinusitis, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luke Rudmik, MD (403-212-8223 ext. 05851, Lukerudmik@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinonasal mucosal healing (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01024075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2009.