Chronic Sinusitis
Conditions
Brief summary
The purpose of this study is to evaluate a stenting material called Nasopore. This is a synthetic material approved by FDA for use as a stent in postoperative sinus surgery patients. This study will compare the Nasopore stent to other approved stenting materials.
Detailed description
This study will compare other sinus stenting products to the Nasopore stent. The stents will be soaked in antibiotic solutions and be observed for how well they perform. Subjects will have a stent placed in each sinus, stents may be the standard antibiotic saturated materials or the new nasopore material or nasopore stent soaked in antibiotics.
Interventions
DRUGMerogel Nasal Stent and Nasopore Stent
Merogel Nasal Stent and Nasopore Stent
DRUGNasopore Stent and either Gentamycin or Bacitracin
Nasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS)
Sponsors
Lahey Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Evaluation by Otolaryngologist & determined to need endoscopic sinus surgery * Only subjects with Bilateral disease
Exclusion criteria
* Pediatric subjects(under the age of 18)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution | prospective |
Countries
United States
Outcome results
None listed