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

Rhinosinusitis Clinical Trial

Official title:

Comparison of the Efficacy and Complication of Gentamicin and Normal Saline Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis : a Double Blind Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02582099
• Other study ID #: 271/2555(EC1)
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2018
• Source: Mahidol University
• Contact: Nualanong Visitsunthorn, Professor
• Phone: +6624195670
• Email: nualanongv[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Rhinosinusitis
• Sinusitis

Intervention

Drug:
• Gentamicin nasal irrigation
Nasal wash with gentamicin solution
• Normal saline nasal irrigation
Nasal wash with normal saline solution

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of sinusitis		During 1 year after treatment