Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following Endoscopic Sinus Surgery

Study Overview
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Brief Summary
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This study will compare the incidence of post-op infection after sinus surgery using conventional post-op oral antibiotics to the incidence of infection after sinus surgery when a bio-resorbable antibiotic soaked nasal sponge is used in the nasal cavity in lieu of post-op oral antibiotics. The nasal sponge is a routine nasal dressing used after sinus surgery and will therefore be placed in all patients.

Detailed Description
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Sinusitis affects 37 million people each year making it one of the most common health problems in the United States. It has a large impact in direct healthcare expenditures, significant loss of workplace productivity and a greater impact on quality of life than diabetes or congestive heart failure. The most frequently used treatments are medications and/or Functional Endoscopic Sinus Surgery(FESS). 100 subjects undergoing ESS will participate, randomized into two groups, treatment and control. All subjects will have a Nasopore sponge placed into the middle meatus of the nose at the end of the procedure(The sponge is FDA approved and commonly used. Subjects in the treatment group will receive a Nasopore sponge soaked in Bacitracin solution. These subjects will not receive oral antibiotics post-operatively. The control group subjects will have a saline soaked Nasopore sponge laced during surgery and will receive routine oral antibiotics post-operatively. The hypothesis is that subjects who receive the antibiotic soaked nasal sponge in lieu of saline soaked nasal sponge will have infection rates comparable to those who receive systemic antibiotics, but because they will not receive systemic antibiotics, the treated group will have fewer side effects and the cost to treat them will be less.

Official Title
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Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following

Conditions
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Sinusitis, Chronic Sinusitis

Intervention / Treatment
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* Drug: Bacitracin
* Procedure: Nasopore sponge soaked with saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects requiring Endoscopic Sinus Surgery Exclusion Criteria: Pediatric subjects <18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Control group undergoing standard ESS will have a saline soaked Nasopore sponge placed during surgery and will receive routine oral antibiotics post-operatively | Procedure: Nasopore sponge soaked with saline<br>* Nasopore sponge soaked with saline placed during surgery and will receive routine oral antibiotics post-operatively<br>* Other names: Nasopore;|
| Experimental: 2<br>Treatment group undergoing ESS will have Nasopore sponge soaked with Bacitracin, but will not receive oral antibiotics post-operatively | Drug: Bacitracin<br>* Nasopore sponge soaked with Bacitracin, placed in middle meatus of the nose. No post-op oral antibiotics<br>* Other names: Anti-Bacterial;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The two groups of subjects will be compared on clincal & demographic characteristics. Evaluation of any new infection (no or yes). |  | Post surgical evaluations at 2/3 weeks and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and demographic data will be evaluate presence/absence of inflammation of surrounding, adhesions, pain, granulation tissue |  | Evaluated at 2/3 weeks and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sinusitis, Chronic Sinusitis, Nasal Surgery, Functional Endoscopic Sinus Surgery (FESS), Enoscopic Sinus Surgery (ESS)