Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: January 2013
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Procedure: Maxillary Sinus Irrigation
- Twice a day irrigation with 100cc saline for 4 days
- Drug: IV Amoxicillin and Clavulanate acid
- IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.
Arms, Groups and Cohorts in this Clinical Trial
- 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.
- 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.
Outcome Measures for this Clinical Trial
Primary Measures
- CT Scoring
- Time Frame: on recruiting and follow-up
Safety Issue?: No
- Time Frame: on recruiting and follow-up
Secondary Measures
- Quality of life Questionaire
- Time Frame: on recruiting and follow-up
Safety Issue?: No
- Time Frame: on recruiting and follow-up
- Nasal Endoscopy score
- Time Frame: upon recruiting and follow-up
Safety Issue?: No
- Time Frame: upon recruiting and follow-up
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Ohad Ronen Other
Overall Clinical Trial Officials and Contacts
Ohad Ronen, MD Principal Investigator ENT Department, Carmel Medical Center, Haifa
Overall Contact: Ohad Ronen, MD 972-4-8250279 ohadro@clalit.org.il
Related Publications
References
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.
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.
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.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00335309
Study ID Number: ENT-1/2005
ClinicalTrials.gov Identifier: NCT00335309
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00335309
