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

The Adjunctive Use of a Dexamethasone-Sinufoam Mixture on Endoscopic Sinus Surgery Outcomes: A Randomized, Double-Blind, Placebo-controlled Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01024075

Enrollment

Registered

2009-12-02

Start date

2009-11-30

Completion date

2011-05-31

Last updated

2009-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGDexamethasone

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

DRUGSaline

8cc of Saline mixed with Sinufoam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Sinonasal mucosal healing	1 month

Secondary

Measure	Time frame
Sinonasal quality of life (SNOT-22)	1 month

Countries

Canada

Contacts

Primary ContactLuke Rudmik, MD

Lukerudmik@hotmail.com403-212-8223

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026