Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis - Full Text View

Sponsor:	Ohad Ronen
Information provided by (Responsible Party):	Ohad Ronen, Carmel Medical Center
ClinicalTrials.gov Identifier:	NCT00335309

Purpose

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.

Condition	Intervention
Sinusitis	Procedure: Maxillary Sinus Irrigation Drug: IV Amoxicillin and Clavulanate acid

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Sinusitis

Drug Information available for: Amoxicillin sodium Amoxicillin

U.S. FDA Resources

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:

CT Scoring [ Time Frame: on recruiting and follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life Questionaire [ Time Frame: on recruiting and follow-up ] [ Designated as safety issue: No ]
Nasal Endoscopy score [ Time Frame: upon recruiting and follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	October 2005
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335309

Contacts

Contact: Ohad Ronen, MD	972-4-8250279	ohadro@clalit.org.il
Contact: Uri Nechama, MD	972-4-8250279	uri_nechama@clalit.org.il

Locations

Israel
Carmel MC	Recruiting
Haifa, Israel, 34362
Principal Investigator: Ohad - Ronen, MD

Sponsors and Collaborators

Ohad Ronen

Investigators

Principal Investigator:

Ohad Ronen, MD

ENT Department, Carmel Medical Center, Haifa

More Information

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.

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.

Responsible Party:	Ohad Ronen, ENT Physician, Carmel Medical Center
ClinicalTrials.gov Identifier:	NCT00335309 History of Changes
Other Study ID Numbers:	ENT-1/2005, 20051031
Study First Received:	June 8, 2006
Last Updated:	January 16, 2012
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Carmel Medical Center:

chronic rhinosinusitis
sinus irrigation

Additional relevant MeSH terms:

Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Amoxicillin
Anti-Bacterial Agents

Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2012