The primary objective of the study is to evaluate the safety and effectiveness of OCEAN as an adjunct aid in wound healing after nasal/sinus surgery and to demonstrate that OCEAN is non-inferior compared to a steroid-eluting sinus stent.
A multicenter, randomized, single-blinded, controlled, intra-patient non-inferiority study enrolling 110 subjects at up to 13 sites in the United States.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
Biodegradable nasal dressing applied after sinus/nasal surgery
Applied after sinus/nasal surgery
Colorado ENT & Allergy
Colorado Springs, Colorado, United States
Emory University
Atlanta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Louisiana State University Health at Shreveport
Rate of Serious Adverse Events
Rate of serious adverse events related to the use of OCEAN bioresorbable nasal dressing.
Time frame: Up to Day 25
Endoscopic Assessment
Endoscopic assessment of wound healing to compare test-treated and control-treated cavities.
Time frame: Day 25
Rate of Adverse Events
Assessment of all adverse events.
Time frame: Up to Day 90
Endoscopic Evaluation of Sinonasal Cavities
Endoscopic evaluation of sinonasal cavities for to evaluate wound healing.
Time frame: Days 25 and 90
Rate of post-operative interventions
Rate of post-operative interventions, including surgical intervention to separate adhesions, and/or oral steroid intervention, and/or biologics.
Time frame: Up to Day 25 and Day 90
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Shreveport, Louisiana, United States
Centers for Advanced ENT Care
Towson, Maryland, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Health
Houston, Texas, United States
Ogden Clinic
Ogden, Utah, United States
ENT Allergy & Associates
Puyallup, Washington, United States