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Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

Primary Purpose

Sinusitis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Maxillary Sinus Irrigation
IV Amoxicillin and Clavulanate acid
Sponsored by
Ohad Ronen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinusitis focused on measuring chronic rhinosinusitis, sinus irrigation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Carmel MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm 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.

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.

Outcomes

Primary Outcome Measures

CT Scoring

Secondary Outcome Measures

Quality of life Questionaire
Nasal Endoscopy score

Full Information

First Posted
June 8, 2006
Last Updated
October 6, 2013
Sponsor
Ohad Ronen
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1. Study Identification

Unique Protocol Identification Number
NCT00335309
Brief Title
Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ohad Ronen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
chronic rhinosinusitis, sinus irrigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm 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.
Arm Title
2
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Maxillary Sinus Irrigation
Intervention Description
Twice a day irrigation with 100cc saline for 4 days
Intervention Type
Drug
Intervention Name(s)
IV Amoxicillin and Clavulanate acid
Intervention Description
IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.
Primary Outcome Measure Information:
Title
CT Scoring
Time Frame
on recruiting and follow-up
Secondary Outcome Measure Information:
Title
Quality of life Questionaire
Time Frame
on recruiting and follow-up
Title
Nasal Endoscopy score
Time Frame
upon recruiting and follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ohad Ronen, MD
Organizational Affiliation
ENT Department, Carmel Medical Center, Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel MC
City
Haifa
ZIP/Postal Code
34362
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
10629474
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. doi: 10.1016/S0194-5998(00)70135-5.
Results Reference
background
PubMed Identifier
7603703
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. doi: 10.1016/S0194-59989570152-4.
Results Reference
background
PubMed Identifier
12161724
Citation
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. doi: 10.1067/mhn.2002.124847.
Results Reference
background

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Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis

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