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临床试验/NCT01430026
NCT01430026已完成不适用

Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis

Mahidol University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Frequency of sinusitis

研究概览

简要总结

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

详细描述

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:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Frequency of sinusitis

时间窗: 1 year

次要结局

  • Complications of gentamicin nasal irrigation usage(1 year)
  • Frequency of antibiotic usage(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nualanong Visitsunthorn

Professor

Mahidol University

研究点 (1)

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