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CompletedNCT00335309Updated Oct 8, 2013

Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

An interventional study of Maxillary Sinus Irrigation and IV Amoxicillin and Clavulanate acid in Sinusitis, sponsored by Ohad Ronen. Completed at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-10-08.

Sponsored by Ohad Ronen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Sinusitis

Keywords

  • chronic rhinosinusitis
  • sinus irrigation
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In context

Rhinosinusitis

330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.

This study's enrollment of 50 is below the median of 60 across 227 interventional studies indexed under Rhinosinusitis.

Browse Rhinosinusitis studies →

Lead sponsor

This is the only study on the registry with Ohad Ronen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureMaxillary Sinus Irrigation

    Twice a day irrigation with 100cc saline for 4 days

  • DrugIV Amoxicillin and Clavulanate acid

    IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.

06

What researchers measure

Primary outcomes

  1. CT Scoring

    Time frame: on recruiting and follow-up

Secondary outcomes

  1. Quality of life Questionaire

    Time frame: on recruiting and follow-up

  2. Nasal Endoscopy score

    Time frame: upon recruiting and follow-up

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Study locations

1 site
  • Carmel MC
    Haifa, 34362, Israel
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References and documents

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. PubMed 10629474 ↗
  • 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. PubMed 7603703 ↗
  • 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. PubMed 12161724 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00335309
Lead sponsor
Ohad Ronen
Responsible party
Ohad Ronen (ENT Physician, Carmel Medical Center) — Sponsor-investigator
First posted
Jun 9, 2006
Start date
Oct 2005
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Oct 8, 2013

Study contacts

Ohad Ronen, MD
principal investigator · ENT Department, Carmel Medical Center, Haifa

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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