Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis
Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Sinusitis
Phase: N/A
Status: Recruiting
Sponsored by: Mahidol University Official(s) and/or principal investigator(s): Nualanong Visitsunthorn, professor, Principal Investigator, Affiliation: Department of Pediatrics Faculty of Medicine Siriraj Hospital, Mahidol University
Overall contact: Nualanong Visitsunthorn, professor, Phone: (662)4197000, Ext: 5941, Email: sinvs@mahidol.ac.th
Summary
The propose of this study to determine efficacy and complication of gentamicin nasal
irrigation in chronic rhinosinusitis
Clinical Details
Official title: Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis
Study design: Observational Model: Case-Only, Time Perspective: Retrospective
Primary outcome: Frequency of sinusitis
Secondary outcome: Complications of gentamicin nasal irrigation usageFrequency of antibiotic usage
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Nualanong Visitsunthorn, professor, Phone: (662)4197000, Ext: 5941, Email: sinvs@mahidol.ac.th
Faculty of Medicine Siriraj Hospital, Bangkoknoi, Bangkok 10700, Thailand; Recruiting Nualanong Visitsunthorn, professor, Phone: (662)4197000, Ext: 5941, Email: sinvs@mahidol.ac.th Suruthai Kurasirikul, M.D., Phone: (662)4197000, Ext: 5670, Email: mintninny@hotmail.com Nualanong Visitsunthorn, Professor, Principal Investigator Suruthai Kurasirikul, M.D., Sub-Investigator Pakit Vitchyanond, Professor, Sub-Investigator Orathai Piboonpocanun, Associated Professor, Sub-Investigator
Additional Information
Related publications: Fokkens W, Lund V, Mullol J; European Position Paper on Rhinosinusitis and Nasal Polyps group. European position paper on rhinosinusitis and nasal polyps 2007. Rhinol Suppl. 2007;(20):1-136. Review. Desrosiers MY, Salas-Prato M. Treatment of chronic rhinosinusitis refractory to other treatments with topical antibiotic therapy delivered by means of a large-particle nebulizer: results of a controlled trial. Otolaryngol Head Neck Surg. 2001 Sep;125(3):265-9. Uren B, Psaltis A, Wormald PJ. Nasal lavage with mupirocin for the treatment of surgically recalcitrant chronic rhinosinusitis. Laryngoscope. 2008 Sep;118(9):1677-80. doi: 10.1097/MLG.0b013e31817aec47.
Starting date: March 2011
Last updated: September 6, 2011
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