Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis
NCT ID: NCT00335309
Last Updated: 2013-10-08
Study Results
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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COMPLETED
NA
50 participants
INTERVENTIONAL
2005-10-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
The Investigational arm is treated with sinus irrigation with normal saline 0.9% and intravenous antibiotics of Augmentin 1 gram 3 times a day for 4 days, and then per os (PO) Augmentin 875mg twice a day (BID) for another 10 days. The treatment is done while the patient is admitted to the otolaryngology - head and neck surgery department.
Maxillary Sinus Irrigation
Twice a day irrigation with 100cc saline for 4 days
2
The control arm is treated with the same intravenous antibiotics of Augmentin 1 gram 3 times a day for 4 days, and then per os (PO) Augmentin 875mg twice a day (BID) for another 10 days. There is no sinus irrigation with normal saline for this arm. The treatment is done while the patient is admitted to the otolaryngology - head and neck surgery department.
IV Amoxicillin and Clavulanate acid
IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.
Interventions
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Maxillary Sinus Irrigation
Twice a day irrigation with 100cc saline for 4 days
IV Amoxicillin and Clavulanate acid
IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.
Eligibility Criteria
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Inclusion Criteria
* Over 18 years of age
* Signed informed consent
* Not participating in another clinical study
Exclusion Criteria
* Isolated frontal or sphenoidal sinusitis
* Immunosuppressed (diabetes, cancer, etc.)
* Craniofacial deformity
* Allergic fungal sinusitis
* Nasal polyposis
* Rhinosinusitis of dental origin
* Bleeding tendency (e.g., chronic coumadin treatment)
* Patients participating in other clinical study
* Patients with penicillin allergy
* Patients with Augmentin resistant bacteria in cultures
18 Years
80 Years
ALL
No
Sponsors
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Ohad Ronen
OTHER
Responsible Party
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Ohad Ronen
ENT Physician
Principal Investigators
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Ohad Ronen, MD
Role: PRINCIPAL_INVESTIGATOR
ENT Department, Carmel Medical Center, Haifa
Locations
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Carmel MC
Haifa, , Israel
Countries
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References
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Benninger MS, Sedory Holzer SE, Lau J. Diagnosis and treatment of uncomplicated acute bacterial rhinosinusitis: summary of the Agency for Health Care Policy and Research evidence-based report. Otolaryngol Head Neck Surg. 2000 Jan;122(1):1-7. doi: 10.1016/S0194-5998(00)70135-5.
Gliklich RE, Metson R. The health impact of chronic sinusitis in patients seeking otolaryngologic care. Otolaryngol Head Neck Surg. 1995 Jul;113(1):104-9. doi: 10.1016/S0194-59989570152-4.
Benninger MS, Appelbaum PC, Denneny JC, Osguthorpe DJ, Stankiewicz JA. Maxillary sinus puncture and culture in the diagnosis of acute rhinosinusitis: the case for pursuing alternative culture methods. Otolaryngol Head Neck Surg. 2002 Jul;127(1):7-12. doi: 10.1067/mhn.2002.124847.
Other Identifiers
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20051031
Identifier Type: OTHER
Identifier Source: secondary_id
ENT-1/2005
Identifier Type: -
Identifier Source: org_study_id