The objective of this study is to investigate the safety and performance of OCEAN® as an adjunct in wound healing after nasal/sinus surgery by using OCEAN® in patients undergoing nasal/sinus surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Biodegradable nasal dressing
Centers for Advanced ENT Care (CAdENT)
Baltimore, Maryland, United States
Ear Nose and Throat Consultants
Detroit, Michigan, United States
Ogden Clinic
Ogden, Utah, United States
Rate of Serious Adverse Events
Rate of serious adverse events related to the use of the OCEAN bioresorbable nasal dressing post nasal surgery
Time frame: Up to 25 days after surgery
Performance
Endoscopic evaluation of aspects of wound healing as assessed using the Lund-Kennedy Endoscopic Score System (LKS). The LKS assesses various factors like edema, crusting, discharge, polyps, and mucosal inflammation. Each parameter is scored from 0 to 2, with 0 being normal and 2 representing severe findings. Higher scores on the Lund-Kennedy Scale indicate a worse outcome, reflecting more severe disease or poor wound healing. Minimum Value: 0 (This represents no signs of inflammation or disease); Maximum Value: 20 (This indicates the most severe signs of disease or inflammation)
Time frame: Up to 25 days after surgery
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