Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

Not Applicable

Completed

• Conditions: Sinusitis
• Interventions: Procedure: Maxillary Sinus Irrigation; Drug: IV Amoxicillin and Clavulanate acid

• Registration Number: NCT00335309
• Lead Sponsor: Ohad Ronen

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 Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-06-08
• Study First Submitted QC: 2006-06-08
• Study First Posted: 2006-06-09
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-06
• Last Update Posted: 2013-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Maxillary Sinus Irrigation	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.
2	IV Amoxicillin and Clavulanate acid	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.

Primary Outcome Measures

Name	Time	Method
CT Scoring	on recruiting and follow-up

Secondary Outcome Measures

Name	Time	Method
Quality of life Questionaire	on recruiting and follow-up
Nasal Endoscopy score	upon recruiting and follow-up

Trial Locations

Locations (1)

Carmel MC; 🇮🇱 Haifa, Israel