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...
Date First Received: June 8, 2006
Last Updated: July 24, 2008
Verified by: Carmel Medical Center, July 2008
Clinical Trial Phase: N/A | Start Date: October 2005
Overall Status: Recruiting
Estimated Enrollment: 60
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”
Condition Keyword(s):
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: October 2010
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
- Once a day irrigation with 100cc saline for 5 days
- Drug: IV Amoxicillin and Clavulanate acid
- IV Amoxycillin and Clavulanate 1 Gram TID for 5 days.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Sinus Irrigation and IV antibiotics
- Active Comparator: 2
- IV antibiotics alone
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: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Carmel Medical Center
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 oronen@siumed.edu
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 November 19, 2008
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
