Trial Outcomes & Findings for The Use of Antibiotic Sinonasal Rinse After Sinus Surgery (NCT NCT02218307)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

68 participants

Primary outcome timeframe

3 months

Results posted on

2017-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Mupirocin topical antibiotic Mupirocin	Placebo Placebo control for mupirocin Placebo
Overall Study STARTED	34	34
Overall Study COMPLETED	25	33
Overall Study NOT COMPLETED	9	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of Antibiotic Sinonasal Rinse After Sinus Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mupirocin n=25 Participants topical antibiotic Mupirocin	Placebo n=33 Participants Placebo control for mupirocin Placebo	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	26 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Mupirocin n=24 Participants topical antibiotic Mupirocin	Placebo n=32 Participants Placebo control for mupirocin Placebo
Quality of Life in Chronic Rhinosinusitis Patients	23 Units on a scale Standard Deviation 19.23	21 Units on a scale Standard Deviation 17.33

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mupirocin n=25 Participants topical antibiotic Mupirocin	Placebo n=33 Participants Placebo control for mupirocin Placebo
Quality of Life in Chronic Rhinosinusitis Patients	24.8 Units on a scale Standard Deviation 25.64	26.4 Units on a scale Standard Deviation 26.13

Adverse Events

Mupirocin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Roy Casiano

University of Miami

Phone: 305-243-1870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place