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

Condition
Chronic Sinusitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Frequency of sinusitis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric allergy clinic in siriraj hospital
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430026

Locations
Thailand
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Nualanong Visitsunthorn, professor Department of Pediatrics Faculty of Medicine Siriraj Hospital, Mahidol University
  More Information

Publications:
Responsible Party: Nualanong Visitsunthorn, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01430026     History of Changes
Other Study ID Numbers: 004/2554(EC3) 
Study First Received: September 5, 2011
Last Updated: September 17, 2015
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
chronic sinusitis
gentamicin nasal irrigation

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016