Saline Irrigation After Surgery in Patients With Chronic Sinusitis (HVSI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01575223|
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : April 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rhinosinusitis||Device: NeilMed sinus rinse Device: Salinex||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The HVSI STUDY: High Volume Saline Irrigation in the Post-operative Management of Chronic Rhinosinusitis: A Multicenter Randomized Single-Blind Controlled Trial|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Active Comparator: High volume saline irrigation
Patients in this group will receive high volume saline irrigation (NeilMed sinus rinse)
Device: NeilMed sinus rinse
High volume saline irrigation
Placebo Comparator: Placebo
Patients in this group will receive low volume saline irrigation (Salinex)
Low volume saline irrigation
- Sinonasal Outcomes Scale (SNOT-22) [ Time Frame: One month post-operatively ]Subjective scale, completed by patient. Validated scale for chronic sinusitis.
- Lund MacKay score [ Time Frame: 1 month postoperatively ]Objective scale, validated, completed by investigator. Preoperative CT scan is scored based on degree of sinus opacification (0-24).
- Nasal and Sinus Symptom Score (NSS) - Subjective scale [ Time Frame: 1 month post-operatively ]A subjective scale, filled out by the patient, specific to symptoms of sinusitis.
- Perioperative Sinus Endoscopy scale (POSE) [ Time Frame: 1 month post-operatively ]Objective scale, completed by treating physician, to assess sinonasal contents endoscopically. Validated scale.
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): NCT01575223
|University of Calgary Otolaryngology - Head & Neck Surgery|
|Calgary, Alberta, Canada, T5J 3E4|
|Western University Dept. of Otolaryngology - Head & Neck Surgery|
|London, Ontario, Canada, N6A 3K7|
|Ottawa University Otolaryngology - Head & Neck Surgery|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 2N2|
|Principal Investigator:||Ian J Witterick, MD MSc FRCSC||Samuel R Lunenfeld Institute|