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

Chronic rhinosinusitis (CRS) is defined as an inflammation of the nose and
paranasal sinuses lasting more than 12 weeks. Currently, treatment is tailored
to each patient, and may be medical or surgical. Conservative treatment options
include topical and courses of systemic corticosteroids, nasal irrigation with
saline solution, and oral antibiotics (during flares or as long-term treatment
in patients with no serum IgE elevation). Topical corticosteroids are currently
the first-line drugs of choice for treatment of CRS and postoperative
management of functional endoscopic sinus surgery. Their mechanism of action
relies partly on their ability to reduce eosinophilic infiltration directly,
but corticosteroids also act indirectly by reducing cytokine release by the
nasal mucosa and epithelial cells present in nasal polyps. However, the
distribution of CS after topical administration via nasal spray is highly
variable. It is believed that delivery of CS to the ethmoid sinus cavity can
still be optimized, which would improve localized drug performance.In cases
refractory to medical treatment, functional endoscopic sinus surgery is
indicated.
Surgical treatment may fail due to a variety of reasons, including formation of
synechiae, recurrence of nasal polyps, mucosal inflammation, lateralization of
the middle turbinate and ostial stenosis of the operated sinus.Topical nasal CS
therapy after surgical treatment is an established strategy for ensuring more
effective and long-lasting symptomatic benefit, as well as reducing polyp size
and number and preventing polyp recurrence.Within this context, there has been
growing interest in the use of bioabsorbable materials such as SupraGel*,
Surgicel®, and
carboxymethyl cellulose derivatives in the middle meatus in an attempt to
optimize postoperative outcomes and decrease the incidence of epistaxis. Doubts
remain as to whether these materials can decrease the risk of synechiae,
potentiate the use of topical drugs in the postoperative period, or
prevent polyp recurrence.
In this regard, some studies have reported benefit with the use of absorbable
CS-eluting patches and stents in the ethmoid sinus cavity, by reducing
postoperative adhesions, crusting, discomfort and, particularly, local
inflammation.
The use of an absorbable drug-eluting stent containing a topical CS, mometasone
furoate, in a rabbit model, confirmed the local steroid delivery with minimal
systemic absorption. The followed human study, Advance II, of this product has
demonstrated that the stent has significantly reduced post-operative
interventions by 29% with minimal local and systemic adverse effects.
Placement of a slow-release fluticasone propionate dressing in the ethmoid
sinus cavity after ethmoidectomy may, by reducing inflammation, minimize the
aforementioned postoperative complications, improving the success rate of
surgery.

This study is designed to evaluate the safety and performance of SinuBand, a
bioresorbable
fluticasone propionate-eluting sinus dressing in the postoperative management
of FESS in patients
with chronic rhinosinusitis. The study will collect both qualitative and
quantitative data recorded by
the investigators during the procedure to determine safety and efficacy of the
device.
2.1.1 Primary Objective:
The primary objective of this trial is to evaluate the safety of the
investigational product
in patient with chronic sinusitis undergoing FESS.
2.1.2 Secondary Objective:
The secondary objective is to assess the performance of SinuBand in the
improvement of
clinical and endoscopic parameters in patients with chronic rhinosinusitis
following FESS.

Randomized, partialy double-blind, single center, controlled clinical trial.
Patients shall be used as their own controls, with implantation in each
ethmoid sinus with one of the three options: Sinuband with the FP, SinuBand
without FP (the study will be double blind on the presence of the FP) or
regular care with *Merocel* pack At the end of the intervention a block
randomization will establish which side will receive which treatment. The
follow-up period is designed to assess the safety and efficacy of the
fluticasone propionate-eluting sinus dressing.

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 determine which treatment option to be
applied to each of the new ethmoid cavities.
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Time: around 3 hours extra time of the patients divided into 5 visits
Three times: ophtalmologic examination
Twice: collection of urine during 24 hours.
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