The Use of Antibiotic Sinonasal Rinse After Sinus Surgery
1 other identifier
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 10, 2014
CompletedFirst Posted
Study publicly available on registry
August 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
March 9, 2017
CompletedJune 26, 2017
May 1, 2017
3.6 years
July 10, 2014
September 28, 2016
May 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Quality of Life in Chronic Rhinosinusitis Patients
3 months
Study Arms (2)
Mupirocin
ACTIVE COMPARATORtopical antibiotic
Placebo
PLACEBO COMPARATORPlacebo control for mupirocin
Interventions
Eligibility Criteria
You may qualify if:
- Chronic Rhinosinusitis
- Undergoing endoscopic sinus surgery
You may not qualify if:
- Age under 18
- Documented adverse reaction to mupirocin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami Miller School of Medicine, ENT Dept
Miami, Florida, 33136, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Roy Casiano
- Organization
- University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 10, 2014
First Posted
August 18, 2014
Study Start
November 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
June 26, 2017
Results First Posted
March 9, 2017
Record last verified: 2017-05