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

Last updated: August 16, 2018
Sponsor: Mahidol University
Overall Status: Active - Recruiting

Phase

4

Condition

Sinus Infections

Sinusitis

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT02582099
271/2555(EC1)
  • Ages 7-18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Patients who used antibiotic prophylaxis within within 1 year before and 6 monthsafter started gentamicin nasal irrigation

  2. Patients received IVIG within 1 year before and 6 months after started gentamicinnasal irrigation

  3. Patients received IT within 1 year before and 6 months after started gentamicin nasalirrigation

  4. Patients underwent endoscopic sinus surgery within 1 year before and 6 months afterstarted 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

Study Design

Total Participants: 40
Study Start date:
January 01, 2017
Estimated Completion Date:
June 30, 2019

Study 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.

Connect with a study center

  • Faculty of Medicine Siriraj Hospital

    Bangkoknoi, Bangkok 10700
    Thailand

    Active - Recruiting

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