Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

Condition(s) targeted: Sinusitis

Intervention: Maxillary Sinus Irrigation (Procedure); IV Amoxicillin and Clavulanate acid (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Ohad Ronen

Official(s) and/or principal investigator(s):
Ohad Ronen, MD, Principal Investigator, Affiliation: ENT Department, Carmel Medical Center, Haifa

Overall contact:
Ohad Ronen, MD, Phone: 972-4-8250279, Email: ohadro@clalit.org.il

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: CT Scoring

Secondary outcome:

Quality of life Questionaire

Nasal Endoscopy score

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Ohad Ronen, MD, Phone: 972-4-8250279, Email: ohadro@clalit.org.il

Carmel MC, Haifa 34362, Israel; Recruiting
Ohad - Ronen, MD, Principal Investigator

Related 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.

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.

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.

Starting date: October 2005
Last updated: August 2, 2012