Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following Endoscopic Sinus Surgery
NCT ID: NCT00705354
Last Updated: 2012-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2009-01-31
2010-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Control group undergoing standard ESS will have a saline soaked Nasopore sponge placed during surgery and will receive routine oral antibiotics post-operatively
Nasopore sponge soaked with saline
Nasopore sponge soaked with saline placed during surgery and will receive routine oral antibiotics post-operatively
2
Treatment group undergoing ESS will have Nasopore sponge soaked with Bacitracin, but will not receive oral antibiotics post-operatively
Bacitracin
Nasopore sponge soaked with Bacitracin, placed in middle meatus of the nose. No post-op oral antibiotics
Interventions
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Bacitracin
Nasopore sponge soaked with Bacitracin, placed in middle meatus of the nose. No post-op oral antibiotics
Nasopore sponge soaked with saline
Nasopore sponge soaked with saline placed during surgery and will receive routine oral antibiotics post-operatively
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Lahey Clinic
OTHER
Responsible Party
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Principal Investigators
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Peter J. Catalano, M.D.
Role: PRINCIPAL_INVESTIGATOR
Lahey Clinic, Inc.
Locations
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Lahey Clinic, Inc.
Burlington, Massachusetts, United States
Countries
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References
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Catalano PJ, Roffman EJ. Evaluation of middle meatal stenting after minimally invasive sinus techniques (MIST). Otolaryngol Head Neck Surg. 2003 Jun;128(6):875-81. doi: 10.1016/S0194-59980300469-8.
Other Identifiers
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2007-119
Identifier Type: -
Identifier Source: org_study_id
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