Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis
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|ClinicalTrials.gov Identifier: NCT00335309|
Recruitment Status : Completed
First Posted : June 9, 2006
Last Update Posted : October 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Sinusitis||Procedure: Maxillary Sinus Irrigation Drug: IV Amoxicillin and Clavulanate acid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2005|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
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.
Procedure: Maxillary Sinus Irrigation
Twice a day irrigation with 100cc saline for 4 days
Active Comparator: 2
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.
Drug: IV Amoxicillin and Clavulanate acid
IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.
- CT Scoring [ Time Frame: on recruiting and follow-up ]
- Quality of life Questionaire [ Time Frame: on recruiting and follow-up ]
- Nasal Endoscopy score [ Time Frame: upon recruiting and follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335309
|Haifa, Israel, 34362|
|Principal Investigator:||Ohad Ronen, MD||ENT Department, Carmel Medical Center, Haifa|