A Phase 4 interventional study of Merogel Nasal Stent and Nasopore Stent and Nasopore Stent and either Gentamycin or Bacitracin in Chronic Sinusitis, sponsored by Lahey Clinic. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-17.
Sponsored by Lahey Clinic · Phase 4, Interventional, and Treatment
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.
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.
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This study has two arms consiting of 50 subjects each (100 total) Arm 1 will recieve the standard stent (merogel)in their right sinus and a nasopore stent in their left sinus.
Drug: Merogel Nasal Stent and Nasopore Stent
The second arm will consist of 50 new subjects. These 50 subjects will have a nasopore stent placed in the left sinus. The first 25 subjects will have nasopore stent placed postoperatively with a bacitracin soaked nasopore in right sinus the second 25 will have a gentamycin soaked nasopore stent in right sinus.
Drug: Merogel Nasal Stent and Nasopore Stent · Drug: Nasopore Stent and either Gentamycin or Bacitracin
Merogel Nasal Stent and Nasopore Stent
Also known as: Merogel Stent, Nasopore Stent, Bacatracin soaked stent, Gentamicin soaked stent
Nasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS)
Also known as: Merogel Stent, Nasopore Stent, Bacatracin soaked stent, Gentamicin soaked stent
This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution
Time frame: prospective
This study is withdrawn, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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