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Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00335309
First Posted: June 9, 2006
Last Update Posted: October 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ohad Ronen, Carmel Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Ohad Ronen, Carmel Medical Center:

Primary Outcome Measures:
  • CT Scoring [ Time Frame: on recruiting and follow-up ]

Secondary Outcome Measures:
  • Quality of life Questionaire [ Time Frame: on recruiting and follow-up ]
  • Nasal Endoscopy score [ Time Frame: upon recruiting and follow-up ]

Enrollment: 50
Study Start Date: October 2005
Study Completion Date: August 2013
Primary Completion Date: August 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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335309


Locations
Israel
Carmel MC
Haifa, Israel, 34362
Sponsors and Collaborators
Ohad Ronen
Investigators
Principal Investigator: Ohad Ronen, MD ENT Department, Carmel Medical Center, Haifa
  More Information

Publications:
Responsible Party: Ohad Ronen, ENT Physician, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT00335309     History of Changes
Other Study ID Numbers: ENT-1/2005
20051031 ( Other Identifier: CMC 09-0072 )
First Submitted: June 8, 2006
First Posted: June 9, 2006
Last Update Posted: October 8, 2013
Last Verified: October 2013

Keywords provided by Ohad Ronen, 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
Anti-Bacterial Agents
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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