Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00335309

Enrollment

Registered

2006-06-09

Start date

2005-10-31

Completion date

2013-08-31

Last updated

2013-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinusitis

Keywords

chronic rhinosinusitis, sinus irrigation

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
CT Scoring	on recruiting and follow-up

Secondary

Measure	Time frame
Quality of life Questionaire	on recruiting and follow-up
Nasal Endoscopy score	upon recruiting and follow-up

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026