The Use of Antibiotic Sinonasal Rinse After Sinus Surgery

Chronic Rhinosinusitis Clinical Trial

Official title:

The Use of Antibiotic Sinonasal Rinse After Sinus Surgery: A Randomized Double-Blind Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218307
• Other study ID #: 20110846
• Status: Completed
• Phase: Phase 4
• First received: July 10, 2014
• Last updated: July 6, 2015
• Start date: November 2011
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic Rhinosinusitis

• Undergoing endoscopic sinus surgery

Exclusion Criteria:

• Age under 18

• Documented adverse reaction to mupirocin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Rhinosinusitis

Intervention

Drug:
• Mupirocin

• Placebo

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine, ENT Dept	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	3 months	No
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.	3 months	No