Clinical trial NCT00335309: Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Keywords: chronic rhinosinusitis
sinus irrigation
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2006-06-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: CT Scoring
timeFrame: on recruiting and follow-up
Secondary outcomes:
measure: Quality of life Questionaire
timeFrame: on recruiting and follow-up
measure: Nasal Endoscopy score
timeFrame: upon recruiting and follow-up
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel MC
Study officials:
affiliation: ENT Department, Carmel Medical Center, Haifa
name: Ohad Ronen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/S0194-5998(00)70135-5.
citation: 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. doi: 10.1016/S0194-59989570152-4.
citation: 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. doi: 10.1067/mhn.2002.124847.