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Sponsored by: |
Carmel Medical Center |
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Information provided by: | Carmel Medical Center |
ClinicalTrials.gov Identifier: | NCT00335309 |
The purpose of this study is to evaluate the effectiveness of maxillary sinus saline irrigation in conjunction with systemic antibiotic therapy versus systemic antibiotic therapy alone in the management of chronic rhinosinusitis, a prospective randomized controlled trial.
Condition | Intervention |
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Sinusitis |
Procedure: Maxillary Sinus Irrigation Drug: IV Amoxicillin and Clavulanate acid |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effectiveness of Maxillary Sinus Saline Irrigation in Conjunction With Systemic Antibiotic Therapy Versus Systemic Antibiotic Therapy Alone in the Management of Chronic Rhinosinusitis, a Prospective Randomized Controlled Trial |
Estimated Enrollment: | 60 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Sinus Irrigation and IV antibiotics
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Procedure: Maxillary Sinus Irrigation
Once a day irrigation with 100cc saline for 5 days
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2: Active Comparator
IV antibiotics alone
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Drug: IV Amoxicillin and Clavulanate acid
IV Amoxycillin and Clavulanate 1 Gram TID for 5 days.
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Effectiveness of maxillary sinus saline irrigation in conjunction with systemic antibiotic therapy versus systemic antibiotic therapy alone in the management of chronic rhinosinusitis. A prospective randomized controlled trial is being conducted in Carmel Medical Center, Haifa, Israel. Patients are being randomized into one of two arms. One arm receives sinus irrigation with saline in conjunction with IV antibiotics, the control arm receives the same regimen of IV antibiotics without the sinus irrigation. Quality of life, CT scans and nasal endoscopy parameters are collected before and after treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
Contact: Ohad Ronen, MD | 972-4-8250279 | oronen@siumed.edu |
Contact: Uri Nechama, MD | 972-4-8250279 | uri_nechama@clalit.org.il |
Israel | |
Carmel MC | Recruiting |
Haifa, Israel, 34362 | |
Principal Investigator: Ohad - Ronen, MD |
Principal Investigator: | Ohad Ronen, MD | ENT Department, Carmel Medical Center, Haifa |
Responsible Party: | Carmel Medical Center ( Ohad Ronen ) |
Study ID Numbers: | ENT-1/2005, 20051031 |
Study First Received: | June 8, 2006 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00335309 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
chronic rhinosinusitis sinus irrigation |
Amoxicillin Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Clavulanic Acid Clavulanic Acids Sinusitis Amoxicillin-Potassium Clavulanate Combination |
Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Paranasal Sinus Diseases |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Nose Diseases |