Safety and Performance of a Bioabsorbable Fluticasone Propionate-eluting sinus dressing (SinuBand) in the Postoperative management of Functional Endoscopic Sinus Surgery in patients with Chronic Rhinosinusitis

Safety and Performance of a Bioabsorbable Fluticasone Propionate-eluting sinus dressing (SinuBand) in the Postoperative management of Functional Endoscopic Sinus Surgery in patients with Chronic Rhinosinusitis - Sinuband in CRS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38446

Enrollment

Registered

2013-07-08

Start date

2013-07-17

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

chronic rhinosinusitis nasal polyps

Interventions

At the end of the endonasal portion of the FESS procedure the operating surgeon shall place either SinuBand with FP, Sinuband without FP or regular *Merocel* pack. Randomization by block of 6 will d

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients aged >18 years, with chronic rhinosinusitis (with nasal polyps), in whom bilateral endoscopic endonasal anterior and posterior ethmoidectomy is indicated due to failure of medical treatment, whether as first surgical approach or as revision surgery.

Exclusion criteria

Exclusion criteria: Patients with a known history of corticosteroid (CS) intolerance will be excluded from the study, as well as those dependent on oral CS or with a history of immunodeficiency, fungal rhinosinusitis, previous nasal polyp surgery in which the middle turbinates have been removed on one or both sides, severe asthma, glaucoma, cataract, or insulin-dependent diabetes mellitus. Patients with known hypersensitivity to any component of SinuBand will be excluded from the study

Design outcomes

Primary

Measure	Time frame
Local sinus safety will be assessed by monitoring for device-related adverse events. Ocular safety will be characterized via baseline and follow-up (day 15 and 30) measurement of intraocular pressure (IOP) and examination for lens opacities. Systemic safety will be evaluated through the measure of the cortisol in 24h urine collection at day minus 1 and at day 15. . .	—

Secondary

Measure	Time frame
Reduction in ethmoid inflammation (graded in a visual analog scale 0 to 100 mm) at any time during follow up (±2) 5, 15, 30 and 60 days) in the SinuBand FP arm compare to the controls. Synechiae and postoperative intervention as surgical intervention to separate an adhesion or oral steroid intervention for recurrent ethmoid inflammation edema and /or polyp recurrence at 30 days will also be measured. The secondary outcome measures will be evaluated from video-endoscopies reviewed by blinded independent panel of 3 ENT surgeons	—

Measure

Time frame

Reduction in ethmoid inflammation (graded in a visual analog scale 0 to 100 mm) at any time during follow up (±2) 5, 15, 30 and 60 days) in the SinuBand FP arm compare to the controls. Synechiae and postoperative intervention as surgical intervention to separate an adhesion or oral steroid intervention for recurrent ethmoid inflammation edema and /or polyp recurrence at 30 days will also be measured. The secondary outcome measures will be evaluated from video-endoscopies reviewed by blinded independent panel of 3 ENT surgeons

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)