Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Nualanong Visitsunthorn, Mahidol University
ClinicalTrials.gov Identifier:
NCT01430026
First received: September 5, 2011
Last updated: September 6, 2011
Last verified: September 2011
  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 ]

Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: March 2012
Estimated 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

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

Contacts
Contact: Nualanong Visitsunthorn, professor (662)4197000 ext 5941 sinvs@mahidol.ac.th
Contact: Suruthai Kurasirikul, M.D. (662)4197000 ext 5670 mintninny@hotmail.com

Locations
Thailand
Faculty of Medicine Siriraj Hospital Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Nualanong Visitsunthorn, professor    (662)4197000 ext 5941    sinvs@mahidol.ac.th   
Contact: Suruthai Kurasirikul, M.D.    (662)4197000 ext 5670    mintninny@hotmail.com   
Principal Investigator: Nualanong Visitsunthorn, Professor         
Sub-Investigator: Suruthai Kurasirikul, M.D.         
Sub-Investigator: Pakit Vitchyanond, Professor         
Sub-Investigator: Orathai Piboonpocanun, Associated Professor         
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 6, 2011
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
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014