Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis
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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.
Condition | Intervention |
---|---|
Sinusitis |
Procedure: Maxillary Sinus Irrigation Drug: IV Amoxicillin and Clavulanate acid |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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 |
- CT Scoring [ Time Frame: on recruiting and follow-up ] [ Designated as safety issue: No ]
- Quality of life Questionaire [ Time Frame: on recruiting and follow-up ] [ Designated as safety issue: No ]
- Nasal Endoscopy score [ Time Frame: upon recruiting and follow-up ] [ Designated as safety issue: No ]
Estimated Enrollment: | 60 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: 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.
|
Procedure: Maxillary Sinus Irrigation
Twice a day irrigation with 100cc saline for 4 days
|
Active Comparator: 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.
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Drug: IV Amoxicillin and Clavulanate acid
IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.
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Detailed Description:
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 to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Contact: Ohad Ronen, MD | 972-4-8250279 | ohadro@clalit.org.il |
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 |
Publications:
Responsible Party: | Ohad Ronen, ENT Physician, Carmel Medical Center |
ClinicalTrials.gov Identifier: | NCT00335309 History of Changes |
Other Study ID Numbers: | ENT-1/2005, 20051031 |
Study First Received: | June 8, 2006 |
Last Updated: | August 2, 2012 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Carmel Medical Center:
chronic rhinosinusitis sinus irrigation |
Additional relevant MeSH terms:
Sinusitis Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Amoxicillin Anti-Bacterial Agents |
Amoxicillin-Potassium Clavulanate Combination Clavulanic Acids Clavulanic Acid Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 16, 2012