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Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis

M

Mahidol University

Status

Completed

Conditions

Chronic Sinusitis

Study type

Observational

Funder types

Other

Identifiers

NCT01430026
004/2554(EC3)

Details and patient eligibility

About

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

Full 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

Enrollment

40 patients

Sex

All

Volunteers

No 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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