Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nualanong Visitsunthorn, Mahidol University
ClinicalTrials.gov Identifier:
NCT01430026
First received: September 5, 2011
Last updated: September 17, 2015
Last verified: September 2015

September 5, 2011
September 17, 2015
March 2011
January 2012   (final data collection date for primary outcome measure)
Frequency of sinusitis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01430026 on ClinicalTrials.gov Archive Site
  • Complications of gentamicin nasal irrigation usage [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Frequency of antibiotic usage [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis
Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis
The propose of this study to determine efficacy and complication of gentamicin nasal irrigation in chronic rhinosinusitis

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
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
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Non-Probability Sample
pediatric allergy clinic in siriraj hospital
Chronic Sinusitis
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01430026
004/2554(EC3)
No
Not Provided
Not Provided
Nualanong Visitsunthorn, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Nualanong Visitsunthorn, professor Department of Pediatrics Faculty of Medicine Siriraj Hospital, Mahidol University
Mahidol University
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP