- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00705354
Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following Endoscopic Sinus Surgery
Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Massachusetts
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Burlington, Massachusetts, United States, 01805
- Lahey Clinic, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects requiring Endoscopic Sinus Surgery
Exclusion Criteria:
- Pediatric subjects <18 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
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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Nasopore sponge soaked with saline placed during surgery and will receive routine oral antibiotics post-operatively
Other Names:
|
Experimental: 2
Treatment group undergoing ESS will have Nasopore sponge soaked with Bacitracin, but will not receive oral antibiotics post-operatively
|
Nasopore sponge soaked with Bacitracin, placed in middle meatus of the nose.
No post-op oral antibiotics
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The two groups of subjects will be compared on clincal & demographic characteristics. Evaluation of any new infection (no or yes).
Time Frame: Post surgical evaluations at 2/3 weeks and 3 months
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Post surgical evaluations at 2/3 weeks and 3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical and demographic data will be evaluate presence/absence of inflammation of surrounding, adhesions, pain, granulation tissue
Time Frame: Evaluated at 2/3 weeks and 3 months
|
Evaluated at 2/3 weeks and 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter J. Catalano, M.D., Lahey Clinic, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-119
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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