Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ohad Ronen, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT00335309
First received: June 8, 2006
Last updated: October 6, 2013
Last verified: October 2013
  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:


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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 8, 2006
Last Updated: October 6, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Carmel Medical Center:
chronic rhinosinusitis
sinus irrigation

Additional relevant MeSH terms:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Antibiotics, Antitubercular
Clavulanic Acid
Clavulanic Acids
Anti-Infective Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014