Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Sinusitis

Intervention / Treatment
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* Procedure: Maxillary Sinus Irrigation
* Drug: IV Amoxicillin and Clavulanate acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic (over 3 months) maxillary and ethmoidal rhinosinusitis (verified by a CT scan) Over 18 years of age Signed informed consent Not participating in another clinical study Exclusion criteria: A previous sinonasal surgery or craniofacial trauma 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Procedure: Maxillary Sinus Irrigation<br>* Twice a day irrigation with 100cc saline for 4 days<br>|
| Active Comparator: 2<br>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. | Drug: IV Amoxicillin and Clavulanate acid<br>* IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT Scoring |  | on recruiting and follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life Questionaire |  | on recruiting and follow-up | 
| Nasal Endoscopy score |  | upon recruiting and follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic rhinosinusitis, sinus irrigation