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Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

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ClinicalTrials.gov Identifier: NCT00335309
Recruitment Status : Completed
First Posted : June 9, 2006
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
Ohad Ronen, Carmel Medical Center

Tracking Information
First Submitted Date  ICMJE June 8, 2006
First Posted Date  ICMJE June 9, 2006
Last Update Posted Date October 8, 2013
Study Start Date  ICMJE October 2005
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2007)
CT Scoring [ Time Frame: on recruiting and follow-up ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2006)
  • CT Scoring
  • Nasal Endoscopy
Change History Complete list of historical versions of study NCT00335309 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2007)
  • Quality of life Questionaire [ Time Frame: on recruiting and follow-up ]
  • Nasal Endoscopy score [ Time Frame: upon recruiting and follow-up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2006)
Quality of life Questionaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sinusitis
Intervention  ICMJE
  • Procedure: Maxillary Sinus Irrigation
    Twice a day irrigation with 100cc saline for 4 days
  • Drug: IV Amoxicillin and Clavulanate acid
    IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Maxillary Sinus Irrigation
  • 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.
    Intervention: Drug: IV Amoxicillin and Clavulanate acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2013)
50
Original Enrollment  ICMJE
 (submitted: June 8, 2006)
60
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00335309
Other Study ID Numbers  ICMJE ENT-1/2005
20051031 ( Other Identifier: CMC 09-0072 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ohad Ronen, Carmel Medical Center
Study Sponsor  ICMJE Ohad Ronen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ohad Ronen, MD ENT Department, Carmel Medical Center, Haifa
PRS Account Carmel Medical Center
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP