The Novapak study is a prospective, observational, multi-site, non-controlled, non-randomized, case-series, with a 2 week and 1-month follow-up in adults undergoing nasal/sinus surgery with Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively and is being conducted to obtain clinical data on the safety and effectiveness of the Novapak device under use as intended in the device indications.
The primary objective is to assess the safety of the Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively in patients undergoing nasal/sinus surgery by: * Collecting all AEs directly attributed to the device and/or those that cannot be determined; and calculating a point estimate and confidence interval * Collecting all AEs and calculating an overall rate and safety profile for the device The secondary objectives are to confirm device effectiveness through assessing adhesions, bleeding, healing and health during the procedure, 2 weeks and 1-month post treatment.
Study Type
OBSERVATIONAL
Enrollment
86
Potential subjects will have the need to undergo nasal/sinus surgery using a space-occupying stent and will perform daily self-saline nasal irrigations.
ENT Associates of South Florida
Boca Raton, Florida, United States
University of Miami
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
St. Joseph's Health Care
London, Onterio, Canada
Safety Assessment - Adverse Events Related to Device
Outcome Measure #1 for the Primary Outcome is the total number of Adverse Events that are directly attributed to the device and/or those that cannot be determined.
Time frame: 30 days
Safety Assessment - All Adverse Events
Outcome Measure #2 for the Primary Outcome is the total number of Adverse Events.
Time frame: 30 days
Effectiveness Assessment - Total Number of Adhesions at Day 14 and Day 30 Post Treatment
Outcome Measure #3 for the Secondary Outcome Measures is number of adhesions observed by endoscopic examination from procedure through 1-month post treatment.
Time frame: 30 days
Effectiveness Assessment - Adhesion Grade at Day 14 and Day 30 Post Treatment
Outcome Measure #4 for the Secondary Outcome Measures is the graded percentage of vertical height of the middle turbinate taken up by the adhesion using an ordinal scale (0-3), where '0' is No Adhesion Present, and '3' is \>50% of middle turbinate height. This scoring is the Valentine method, and participants are graded based on their endoscopic examination.
Time frame: 30 days
Effectiveness Assessment - Bleeding Control
Outcome Measure #5 for the Secondary Outcome Measures is to measure control of bleeding by comparing Boezaart Surgical Field Grading Scale scores post operatively, prior to Novapak insertion and post Novapak insertion. The Boezaart scale grades bleeding from Grade 0: No Bleeding through Grade 5: Severe Bleeding.
Time frame: 1 day
Effectiveness Assessment - Healing
Outcome Measure #6 for the Secondary Outcome Measures is to measure healing by comparing Lund-Kennedy scores before surgery and at 2 weeks and 1-month post treatment. The Lund-Kennedy Scoring minimum is 0 and maximum is 10, with higher scores indicating worse observed disease. The Lund-Kennedy grading system is as follows: Nasal Polyps 0 = none; 1 = confined to middle meatus; 2 = beyond middle meatus Discharge 0 = none; 1 = clear and thin; 2 = thick and purulent Edema 0 = absent; 1 = mild; 2 = severe Scarring 0 = absent; 1 = mild; 2 = severe Crusting 0 = absent; 1 = mild; 2 = severe Numerical values for each term are summed for each sinus analyzed; and mean averages are reported.
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Time frame: 30 day
Effectiveness Assessment - Health Assessment
Outcome Measure #7 for the Secondary Outcome Measures is to measure health by comparing subject scores from the SNOT-22 questionnaire before surgery and at 2 weeks and 1-month post treatment. The Sino-Nasal Outcome Test (SNOT-22) is a validated questionnaire used to assess the severity of 22 symptoms related to the nasal sinuses using a 0-5-point scale (0 = No problem; 1 = Very mild problem; 2 = Mild or slight problem; 4 = Moderate problem; 5 = Problem as bad as it can be). Minimum score: 0; Maximum score: 110. The higher the score the worse the problems are.
Time frame: 30 day