Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

Ohad Ronen

Status: Completed

Conditions: Sinusitis

Treatments: Drug: IV Amoxicillin and Clavulanate acid; Procedure: Maxillary Sinus Irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT00335309

20051031 (Other Identifier)

ENT-1/2005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Procedure: Maxillary Sinus Irrigation

2

Active Comparator group

Description:

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.

Treatment:

Drug: IV Amoxicillin and Clavulanate acid