Chronic Rhinosinusitis
Conditions
Brief summary
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.
Interventions
DRUGMupirocin
DRUGPlacebo
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic Rhinosinusitis * Undergoing endoscopic sinus surgery
Exclusion criteria
* Age under 18 * Documented adverse reaction to mupirocin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life in Chronic Rhinosinusitis Patients | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life in Chronic Rhinosinusitis Patients | 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mupirocin topical antibiotic
Mupirocin | 25 |
| Placebo Placebo control for mupirocin
Placebo | 33 |
| Total | 58 |
Baseline characteristics
| Characteristic | Mupirocin | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 7 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 26 Participants | 46 Participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 24 Participants |
| Sex: Female, Male Male | 14 Participants | 20 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 33 |
| serious Total, serious adverse events | 0 / 25 | 0 / 33 |
Outcome results
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mupirocin | Quality of Life in Chronic Rhinosinusitis Patients | 23 Units on a scale | Standard Deviation 19.23 |
| Placebo | Quality of Life in Chronic Rhinosinusitis Patients | 21 Units on a scale | Standard Deviation 17.33 |
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mupirocin | Quality of Life in Chronic Rhinosinusitis Patients | 24.8 Units on a scale | Standard Deviation 25.64 |
| Placebo | Quality of Life in Chronic Rhinosinusitis Patients | 26.4 Units on a scale | Standard Deviation 26.13 |