Phase 4 N=29 Randomized Single-blind Treatment

Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel

Ethmoid Sinusitis · Rhinosinusitis

Bottom Line

View on ClinicalTrials.gov: NCT00554190 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Apr 2009

Primary outcome: Primary: Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale — 14; 13; 4; 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: AdvaCoat sinus gel (Device); Merogel Injectable (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Carbylan Therapeutics, Inc.
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale	14; 13; 4; 5; 1; 1	—
PRIMARY Number of Participants With Solicited and Recorded Adverse Events	1; 2; 2; 2	—

Summary

The purpose of this study is to evaluate the safety and effectiveness of AdvaCoat® sinus gel, a nasal/sinus dressing, for adhesion prevention following endoscopic ethmoid sinus surgery. Subjects were randomized to receive AdvaCoat applied to the right or left middle meatus tissues and Merogel applied to the middle meatus tissues on the opposite side.

Eligibility Criteria

Inclusion Criteria

Patients who:

Have bilateral chronic rhinosinusitis confirmed by physical exam, clinical history, and prior radiography
Have bilateral ethmoid sinus disease
Are scheduled for bilateral anterior or total ethmoidectomy

Exclusion Criteria

Unilateral ethmoid sinus disease
Partial resection of middle turbinates, unilateral or bilateral

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00554190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.