Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

STUDY DESIGN This is a single-blinded Randomized Control Trial study, in which every patient
receives active gel on one side and placebo on the other (L or R to be randomly selected).
Sixty patients will be included in this study. These are patients undergoing balloon
sinuplasty for Chronic sinusitis with and without polyps.

As the patients will enter the study- they will be divided into Chronic sinusitis with Polyps
(CRSwNP) and Chronic rhinosinusitis without polyps (CRSsNP). Each patient will be assigned in
chronological order as they will join the study.

For each group, all even numbered patients will receive the active gel application on right
side and all odd number patients will receive the active gel on left side.

Then patient selection for CRSwNP and CRSsNP will be as such Each group will have 3
subgroups. Subgroup 1- gel will be loaded with steroids only Subgroup 2- gel will be loaded
with antibiotic (Levaquin) only Subgroup 3- gel will be loaded with both steroids and
antibiotic CRSwNP group with right side gel application Subgroup 1- patient number-
1,7,13,19,25 Subgroup 2- patient number- 3,9,15,21,27 Subgroup 3- patient number-
5,11,17,23,29 CRSwNP group with left side gel application Subgroup 1- patient number-
2,8,14,20,26 Subgroup 2- patient number- 4,10,16,22,28 Subgroup 3- patient number-
6,12,18,24,30

A similar patient randomization will be done with the CRSsNP group

Surgery will consist of plain balloon sinuplasty or hybrid balloon sinuplasty with removal of
ethmoids polypss using a Blakesley forceps. During surgery, and immediately after removal of
diseased mucosa, 5 ccs of an active poloxamer gel containing the antibiotic or
corticosteroids or both will be instilled inside the ethmoid/ maxillary sinus/frontal
cavities on one side using either the balloon catheter or as a curved suction tip. The same
procedure is performed in the other side, this time with instillation of plain gel without
antibiotic or corticosteroids (placebo).

The purpose of the study is to assess the efficacy of intra-sinus installation of a poloxamer
gel that releases antibiotics and corticosteroids topically after balloon sinuplasty in
chronic sinusitis patients with or without polyps. The assessment of the healing process will
be done at the end of one month then at two, three and six months. Total number of visits
would be 8 including the operation day.

Inclusion Criteria:

1. Chronic sinusitis symptoms with or without polyps

2. Trial of at least 2 courses of oral antimicrobial treatment without significant
improvement

3. CAT scan showing evidence of bilateral symmetric chronic sinusitis with or without
polypss

4. Endoscopic confirmation of CRS

Exclusion Criteria:

1. Minor (Less than <18 years of age).

2. Pregnant and breastfeeding women.

3. Allergy to specific antibiotics

4. Patient currently taking oral corticosteroids.

5. Patient currently taking oral antibiotics.