Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

Sinusitis Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335309
• Other study ID #: ENT-1/2005
• Secondary ID: 20051031
• Status: Completed
• Phase: N/A
• First received: June 8, 2006
• Last updated: October 6, 2013
• Start date: October 2005
• Est. completion date: August 2013

Study information

• Verified date: October 2013
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Sinusitis

Intervention

Procedure:
• Maxillary Sinus Irrigation
Twice a day irrigation with 100cc saline for 4 days

Drug:
• IV Amoxicillin and Clavulanate acid
IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.

Locations

Country	Name	City	State
Israel	Carmel MC	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Ohad Ronen

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CT Scoring		on recruiting and follow-up	No
Secondary	Quality of life Questionaire		on recruiting and follow-up	No
Secondary	Nasal Endoscopy score		upon recruiting and follow-up	No