Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Double blind placebo controlled trial to evaluate whether the routine use of nasal irrigation with mupirocin is more effective than saline irrigations alone in reducing symptoms of chronic rhinosinusitis in the early postoperative period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mupirocin | Active Comparator | topical antibiotic |
|
| Placebo | Placebo Comparator | Placebo control for mupirocin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mupirocin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life in Chronic Rhinosinusitis Patients | Measuring the quality of life in chronic rhinosinusitis through completion of a questionnaire named SNOT 20 ( 20 questions for Sino-Nasal Outcome Test) Snot20: Scale 1 to 5 for 20 symptoms numbered below where 5 is the worst symptom. Total SNOT is scale from 0-100 where 100 is the worst. The following are the elements: 1. need to blow 2. sneezing 3. runny nose 4. cough 5. postnasal drip 6. Thick nasal discharge 7. Ear fullness 8. Dizziness 9. Ear pain 10. facial pain/pressure 11. difficulty falling asleep 12. wake up at night 13. lack of a good night's sleep 14. wake up tired 15. Fatigue 16. Reduced productivity 17. Reduced concentration 18. frustrated/ restless/irritable 19. sad 20. Embarrassed | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life in Chronic Rhinosinusitis Patients | Measuring the quality of life in chronic rhinosinusitis through completion of a questionnaire named Visual Analog Scale for Nasal Obstruction/Congestion. VAS for nasal obstruction is scale from 0 to 100 where 100 mean worse. | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine, ENT Dept | Miami | Florida | 33136 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mupirocin | topical antibiotic Mupirocin |
| FG001 | Placebo | Placebo control for mupirocin Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mupirocin | topical antibiotic Mupirocin |
| BG001 | Placebo | Placebo control for mupirocin Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quality of Life in Chronic Rhinosinusitis Patients | Measuring the quality of life in chronic rhinosinusitis through completion of a questionnaire named SNOT 20 ( 20 questions for Sino-Nasal Outcome Test) Snot20: Scale 1 to 5 for 20 symptoms numbered below where 5 is the worst symptom. Total SNOT is scale from 0-100 where 100 is the worst. The following are the elements: 1. need to blow 2. sneezing 3. runny nose 4. cough 5. postnasal drip 6. Thick nasal discharge 7. Ear fullness 8. Dizziness 9. Ear pain 10. facial pain/pressure 11. difficulty falling asleep 12. wake up at night 13. lack of a good night's sleep 14. wake up tired 15. Fatigue 16. Reduced productivity 17. Reduced concentration 18. frustrated/ restless/irritable 19. sad 20. Embarrassed | Posted | Mean | Standard Deviation | Units on a scale | 3 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mupirocin | topical antibiotic Mupirocin |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roy Casiano | University of Miami | 305-243-1870 | rcasiano@miami.edu |
Not provided
| ID | Term |
|---|---|
| D016712 | Mupirocin |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Placebo |
Placebo control for mupirocin Placebo |
|
|
| Secondary | Quality of Life in Chronic Rhinosinusitis Patients | Measuring the quality of life in chronic rhinosinusitis through completion of a questionnaire named Visual Analog Scale for Nasal Obstruction/Congestion. VAS for nasal obstruction is scale from 0 to 100 where 100 mean worse. | Posted | Mean | Standard Deviation | Units on a scale | 3 months |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Placebo | Placebo control for mupirocin Placebo | 0 | 33 | 0 | 33 |
Not provided
Not provided
Not provided
| D011714 |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |