Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis
Information source: Carmel Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sinusitis
Intervention: Maxillary Sinus Irrigation (Procedure); IV Amoxicillin and Clavulanate acid (Drug)
Sponsored by: Ohad Ronen
Official(s) and/or principal investigator(s):
Ohad Ronen, MD, Principal Investigator, Affiliation: ENT Department, Carmel Medical Center, Haifa
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
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: CT Scoring
Quality of life Questionaire
Nasal Endoscopy score
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.
Minimum age: 18 Years.
Maximum age: 80 Years.
- Chronic (over 3 months) maxillary and ethmoidal rhinosinusitis (verified by a CT
- Over 18 years of age
- Signed informed consent
- Not participating in another clinical study
- 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
Locations and Contacts
Carmel MC, Haifa 34362, Israel
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.
Starting date: October 2005
Last updated: October 6, 2013