The Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis

Phase 4

• Conditions: Rhinosinusitis
• Interventions: Drug: Normal saline nasal irrigation; Drug: Gentamicin nasal irrigation

• Registration Number: NCT02582099
• Lead Sponsor: Mahidol University

Brief Summary

Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect. In pediatrics allergy clinic at Siriraj hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have been no prospective studies in gentamicin 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. Nasal lavage with Mupirocin represent an effective and well tolerated alternative treatment of surgically recalcitrant chronic rhinosinusitis. Gentamicin irrigation should be helpful in chronic rhinosinusitis.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Study Start: 2017-01-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-20
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Chronic rhinosinusitis and/or recurrent acute/subacute sinusitis patients who were followed in pediatrics allergy clinic at Siriraj hospital between December 4, 2012, and December 3, 2016

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Exclusion Criteria

1. Patients who used antibiotic prophylaxis within within 1 year before and 6 months after started gentamicin nasal irrigation
2. Patients received IVIG within 1 year before and 6 months after started gentamicin nasal irrigation
3. Patients received IT within 1 year before and 6 months after started gentamicin nasal irrigation
4. Patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation
5. Patient who have mental retardation
6. Patient who have aminoglycosides hypersensitivity reactions
7. Pregnancy women and Lactation period
8. Patient who have abnormal hearing test before started gentamicin nasal irrigation
9. Patient who have chronic rhinosinusitis with nasal polyp

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline nasal irrigation	Normal saline nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril
Gentamicin	Gentamicin nasal irrigation	Gentamicin nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril

Primary Outcome Measures

Name	Time	Method
Frequency of sinusitis	During 1 year after treatment

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand