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

Primary Purpose

Rhinosinusitis

Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Gentamicin nasal irrigation
Normal saline nasal irrigation
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinosinusitis

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Medicine Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gentamicin

Normal saline

Arm Description

Gentamicin nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril

Normal saline nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril

Outcomes

Primary Outcome Measures

Frequency of sinusitis

Secondary Outcome Measures

Full Information

First Posted
October 20, 2015
Last Updated
August 16, 2018
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02582099
Brief Title
The Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinosinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gentamicin
Arm Type
Active Comparator
Arm Description
Gentamicin nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Normal saline nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril
Intervention Type
Drug
Intervention Name(s)
Gentamicin nasal irrigation
Intervention Description
Nasal wash with gentamicin solution
Intervention Type
Drug
Intervention Name(s)
Normal saline nasal irrigation
Intervention Description
Nasal wash with normal saline solution
Primary Outcome Measure Information:
Title
Frequency of sinusitis
Time Frame
During 1 year after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Patients who used antibiotic prophylaxis within 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 received IT 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 Patient who have mental retardation Patient who have aminoglycosides hypersensitivity reactions Pregnancy women and Lactation period Patient who have abnormal hearing test before started gentamicin nasal irrigation Patient who have chronic rhinosinusitis with nasal polyp
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nualanong Visitsunthorn, Professor
Phone
+6624195670
Email
nualanongv@yahoo.com
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nualanong Visitsunthorn, prof
Phone
(662)4197000
Ext
5941
Email
sinvs@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Nualanong Visitsunthorn, Prof

12. IPD Sharing Statement

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

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