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Sponsored by: |
Lahey Clinic |
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Information provided by: | Lahey Clinic |
ClinicalTrials.gov Identifier: | NCT00705354 |
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.
Condition | Intervention |
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Sinusitis Chronic Sinusitis |
Drug: Bacitracin Procedure: Nasopore sponge soaked with saline |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following |
Estimated Enrollment: | 100 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Control group undergoing standard ESS will have a saline soaked Nasopore sponge placed during surgery and will receive routine oral antibiotics post-operatively
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Procedure: Nasopore sponge soaked with saline
Nasopore sponge soaked with saline placed during surgery and will receive routine oral antibiotics post-operatively
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2: Experimental
Treatment group undergoing ESS will have Nasopore sponge soaked with Bacitracin, but will not receive oral antibiotics post-operatively
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Drug: Bacitracin
Nasopore sponge soaked with Bacitracin, placed in middle meatus of the nose. No post-op oral antibiotics
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Peter J. Catalano, M.D. | 781-744-8450 | Peter.J.Catalano@Lahey.org |
Contact: Joanne Bilmazes | 781-744-5088 | Joanne.Bilmazes@Lahey.org |
United States, Massachusetts | |
Lahey Clinic, Inc. | Recruiting |
Burlington, Massachusetts, United States, 01805 | |
Contact: Joanne Bilmazes 781-744-5088 Joanne.Bilmazes@Lahey.org | |
Principal Investigator: Peter J. Catalano, M.D. | |
Sub-Investigator: Tamara Rimash, M.D. | |
Sub-Investigator: Shridhar Ventrapragada, M.D. |
Principal Investigator: | Peter J. Catalano, M.D. | Lahey Clinic, Inc. |
Responsible Party: | Lahey Clinic, Inc. ( Peter J. Catalano, M.D. ) |
Study ID Numbers: | 2007-119 |
Study First Received: | June 24, 2008 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00705354 History of Changes |
Health Authority: | United States: Institutional Review Board |
Sinusitis Chronic Sinusitis Nasal Surgery Functional Endoscopic Sinus Surgery (FESS) Enoscopic Sinus Surgery (ESS) |
Anti-Infective Agents, Local Anti-Bacterial Agents Otorhinolaryngologic Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Chronic Disease Bacitracin Sinusitis |
Anti-Infective Agents Disease Attributes Otorhinolaryngologic Diseases Paranasal Sinus Diseases Sinusitis Bacitracin Pharmacologic Actions Nose Diseases |
Anti-Bacterial Agents Anti-Infective Agents, Local Pathologic Processes Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Chronic Disease |