Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis

Chronic Sinusitis Clinical Trial

Official title:

Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430026
• Other study ID #: 004/2554(EC3)
• Status: Completed
• Phase: N/A
• First received: September 5, 2011
• Last updated: September 17, 2015
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: September 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Sinusitis

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of sinusitis		1 year	No
Secondary	Complications of gentamicin nasal irrigation usage		1 year	Yes
Secondary	Frequency of antibiotic usage		1 year	No