Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01430026

Enrollment

Registered

2011-09-07

Start date

2011-03-31

Completion date

2012-03-31

Last updated

2015-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Sinusitis

Keywords

chronic sinusitis, gentamicin nasal irrigation

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Frequency of sinusitis	1 year

Secondary

Measure	Time frame
Complications of gentamicin nasal irrigation usage	1 year
Frequency of antibiotic usage	1 year

Countries

Thailand

Outcome results