Clinical trial NCT01430026: Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis
Official title: Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Sinusitis
Keywords: chronic sinusitis
gentamicin nasal irrigation
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric allergy clinic in siriraj hospital

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

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 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

Primary outcomes:
measure: Frequency of sinusitis
timeFrame: 1 year
Secondary outcomes:
measure: Complications of gentamicin nasal irrigation usage
timeFrame: 1 year
measure: Frequency of antibiotic usage
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Department of Pediatrics Faculty of Medicine Siriraj Hospital, Mahidol University
name: Nualanong Visitsunthorn, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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. doi: 10.1067/mhn.2001.117410.
citation: 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.