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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline | Placebo Comparator | Sinufoam is mixed with saline and placed within the ethmoid cavity at the completion of sinus surgery |
|
| Dexamethasone | Active Comparator | Sinufoam is mixed with dexamethasone and placed within the ethmoid cavity at the completion of sinus surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 4cc of Dexamethasone and 4cc of Saline mixed with Sinufoam |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sinonasal mucosal healing | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Sinonasal quality of life (SNOT-22) | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luke Rudmik, MD | Contact | 403-212-8223 | 05851 | Lukerudmik@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luke Rudmik, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Recruiting | Calgary | Alberta | T2N 2T9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22253199 | Derived | 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. |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Saline |
| Drug |
8cc of Saline mixed with Sinufoam |
|
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |