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Principal Investigator left the institution requested study terminated.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Merogel stent vs. Nasopore Stent | Active Comparator | 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. |
|
| bacitracin vs. gentamicin treated stent | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Merogel Nasal Stent and Nasopore Stent | Drug | Merogel Nasal Stent and Nasopore Stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution | prospective |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J. Catalano, MD | Lahey Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Clinic, Inc | Burlington | Massachusetts | 01805 | United States |
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| ID | Term |
|---|---|
| D001414 | Bacitracin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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|
| Nasopore Stent and either Gentamycin or Bacitracin | Drug | Nasopore Stent with Bacitracin (100,000 units in 10cc(NSS)or Gentamycin(80mg in 10cc NSS) |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |