The Use of Antibiotic Sinonasal Rinse After Sinus Surgery

Phase 4

Completed

• Conditions: Chronic Rhinosinusitis
• Interventions: Drug: Mupirocin; Drug: Placebo

• Registration Number: NCT02218307
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-08-15
• Study First Posted: 2014-08-18
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2016-09-28
• Results First Submitted QC: 2017-01-18
• Results First Posted: 2017-03-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-30
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Chronic Rhinosinusitis
• Undergoing endoscopic sinus surgery

Exclusion Criteria

• Age under 18
• Documented adverse reaction to mupirocin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mupirocin	Mupirocin	topical antibiotic
Placebo	Placebo	Placebo control for mupirocin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Miami Miller School of Medicine, ENT Dept; 🇺🇸 Miami, Florida, United States