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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 usage

Frequency 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

Page last updated: August 23, 2015

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