Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

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 Overview

• Status: Completed
• Conditions: Sinusitis
• Intervention / Treatment: Procedure: Maxillary Sinus Irrigation; Drug: IV Amoxicillin and Clavulanate acid

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 34362
    • Carmel MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: IV Amoxicillin and Clavulanate acid; IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CT Scoring	on recruiting and follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life Questionaire	on recruiting and follow-up
Nasal Endoscopy score	upon recruiting and follow-up

Collaborators and Investigators

• Sponsor: Ohad Ronen
• Investigators: Principal Investigator: Ohad Ronen, MD, ENT Department, Carmel Medical Center, Haifa

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: June 8, 2006
• First Submitted That Met QC Criteria: June 8, 2006
• First Posted (Estimate): June 9, 2006

Study Record Updates

• Last Update Posted (Estimate): October 8, 2013
• Last Update Submitted That Met QC Criteria: October 6, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: chronic rhinosinusitis; sinus irrigation
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin; Clavulanic Acid; Clavulanic Acids
• Other Study ID Numbers: ENT-1/2005; 20051031 (Other Identifier: CMC 09-0072)