Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis

Completed

• Conditions: Chronic Sinusitis

• Registration Number: NCT01430026
• Lead Sponsor: Mahidol University

Brief Summary

The propose of this study to determine efficacy and complication of gentamicin nasal irrigation in chronic rhinosinusitis

Detailed Description

Chronic rhinosinusitis (CRS) is characterized by symptoms \> 12 weeks

Two or more symptoms one of which should be either nasal blockage /obstruction/congestion or nasal discharge (anterior/posterior nasal drip):

* facial pain/pressure

* reduction or loss of smell)

Mainstay of treatment are medical and surgical treatment ( ATB, adenoidectomy, ESS) Adjunctive treatment : normal saline nasal irrigation, nasal corticosteroids, nasal decongestants, mucolytics Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect Nasal lavage with Mupirocin represent an effective and well tolerated alternative treatment of surgically recalcitrant chronic rhinosinusitis

In pediatrics allergy clinic at Siriraj hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have been no studies in gentamicin irrigation in chronic rhinosinusitis. The aims of this study are to evaluate:

1. Efficacy of gentamicin nasal irrigation in chronic rhinosinusitis (outcomes: frequency of sinusitis, frequency of antibiotic usage)

2. Complication of gentamicin nasal irrigation usage

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-09-05
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-07
• Primary Completion: 2012-01
• Study Completion: 2012-03
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-17
• Last Update Posted: 2015-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Chronic rhinosinusitis patients who were followed in pediatrics allergy clinic at Siriraj hospital between January 1, 2005, and February 28, 2011
• Gentamicin nasal irrigation usage for longer than 3 months

Exclusion Criteria

• Patients who used azithromycin prophylaxis within 1 year before and 6 months after started gentamicin nasal irrigation
• Patients received IVIG within 1 year before and 6 months after started gentamicin nasal irrigation
• Patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation
• Patients received IT within 1 year before and 6 months after started gentamicin nasal irrigation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of sinusitis	1 year

Secondary Outcome Measures

Name	Time	Method
Complications of gentamicin nasal irrigation usage	1 year
Frequency of antibiotic usage	1 year

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand