Chronic Rhinosinusitis (Diagnosis) Clinical Trial
Official title:
Topical Antibiotics in Chronic Rhinosinusitis
Verified date | March 2022 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Researchers are trying to find out if patients develop antibiotic resistant organisms after the use of topical antibiotics in the treatment of chronic rhinosinusitis.
Status | Completed |
Enrollment | 19 |
Est. completion date | February 1, 2021 |
Est. primary completion date | February 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Male or female, between 18-80 years old, diagnosed with chronic rhinosinusitis who have undergone previous functional endoscopic sinus surgery including at minimum maxillary antrostomy and anterior ethmoidectomy - Active mucopurulence on endoscopic examination with corresponding culture demonstrating pathogenic bacterial growth - Completion of written informed consent - No prior enrollment into this study - Refractory to maximal medical therapy Exclusion Criteria: - Patient has not had prior endoscopic sinus surgery consisting of at minimum maxillary antrostomy and anterior ethmoidectomy - Patient is currently being treated with oral antibiotics - Patient has been treated with oral or topical antibiotics within the past 14 days - Participation in an investigational drug study simultaneously with participation in this study - Concurrent use of oral steroids - Allergy to Tobramycin, Mupirocin, Gentamicin and Levofloxacin - Known to currently be pregnant |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjects Who Developed Antibiotic Resistance Organisms | Number of subjects who developed new antibiotic resistance organisms measured by nasal swab of the affected sinonasal cavity and sent for stain, culture, and sensitivity. | Post-intervention (within 21 days of intervention completion) | |
Secondary | Change in Patient Symptoms as Measured by the Sino-Nasal Outcomes Test (SNOT-22) Survey | Scores are measured from 0-5 in a 22-item validated survey. Total scores range from 0-110 with higher scores indicating greater burden of sinonasal symptoms. | Baseline, Post-intervention (within 21 days of intervention completion) | |
Secondary | Change in Patient Physical Exam as Measured by the Lund-Kennedy Endoscopic Exam Scores. | Scores are measured on a 0-2 scale for nasal polyps, edema, and secretions in both right and left nasal cavities. Total scores range from 0 to 12 with higher scores indicating greater evidence of sinonasal disease on physical exam. | Baseline, Post-intervention (within 21 days of intervention completion) |
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