Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis

NCT ID: NCT01430026

Last Updated: 2015-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-03-31

Brief Summary

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

Detailed Description

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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:

1. Efficacy of gentamicin nasal irrigation in chronic rhinosinusitis (outcomes: frequency of sinusitis, frequency of antibiotic usage)
2. Complication of gentamicin nasal irrigation usage

Conditions

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Chronic Sinusitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Nualanong Visitsunthorn

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nualanong Visitsunthorn, professor

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics Faculty of Medicine Siriraj Hospital, Mahidol University

Locations

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Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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Fokkens W, Lund V, Mullol J; European Position Paper on Rhinosinusitis and Nasal Polyps group. European position paper on rhinosinusitis and nasal polyps 2007. Rhinol Suppl. 2007;20:1-136.

Reference Type BACKGROUND
PMID: 17844873 (View on PubMed)

Desrosiers MY, Salas-Prato M. Treatment of chronic rhinosinusitis refractory to other treatments with topical antibiotic therapy delivered by means of a large-particle nebulizer: results of a controlled trial. Otolaryngol Head Neck Surg. 2001 Sep;125(3):265-9. doi: 10.1067/mhn.2001.117410.

Reference Type BACKGROUND
PMID: 11555764 (View on PubMed)

Uren B, Psaltis A, Wormald PJ. Nasal lavage with mupirocin for the treatment of surgically recalcitrant chronic rhinosinusitis. Laryngoscope. 2008 Sep;118(9):1677-80. doi: 10.1097/MLG.0b013e31817aec47.

Reference Type BACKGROUND
PMID: 18545212 (View on PubMed)

Other Identifiers

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004/2554(EC3)

Identifier Type: -

Identifier Source: org_study_id

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