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Completed

NCT Number: NCT00335309

Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

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.

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Key information

Conditions

Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carmel MC

Haifa, 34362, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maxillary Sinus Irrigation

Procedure

Twice a day irrigation with 100cc saline for 4 days

IV Amoxicillin and Clavulanate acid

Drug

IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.

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

Sponsors and collaborators

Lead sponsor

Ohad Ronen

Other

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Jun 9, 2006
Registry last updated
Oct 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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