Mometasone Furoate, Rhinosinusitis Chronic, Sinus Surgery, Wound Healing
Conditions
Brief summary
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.
Interventions
DEVICEOCEAN
Biodegradable nasal dressing
Sponsors
Polyganics BV
NAMSA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is 18 years or older 2. Patient is scheduled to undergo bilateral endoscopic sinus surgery for Chronic Rhinosinusitis with nasal polyps (CRSwNP) or Chronic Rhinosinusitis without nasal polyps (CRSsNP) 3. Patient is willing and able to comply with all study elements as indicated by their written informed consent 4. Patients with a pre-operative Lund-MacKay score of ≥ 6.
Exclusion criteria
1. Patient is pregnant or nursing 2. Patients with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months 3. Patients with a platelet disorder 4. Patients with a known or suspected allergy to device components 5. Patients with known hemophilia 6. Patients with insulin dependent diabetics 7. Patients with an oral steroid dependent condition 8. Patients with glaucoma, ocular hypertension, posterior subcapsular cataracts 9. Patients with a (previous) diagnosis of Samter's Triad (aspirin-exacerbated respiratory disease (AERD)) 10. Patients that require nasal ointments or creams at time of device placement 11. Patients with a neurological, medical, psychiatric condition, or social circumstance that would potentially increase risk, interfere with study participation, or confound interpretation of study data 12. Patients with plans to (or otherwise anticipate the need to) undergo an ear, nose, throat (ENT) procedure within the 90 day study follow up 13. Patients participating in another clinical research study (within 30 days prior to screening up till 90 days post-operative). 14. Patients that used any form of corticosteroid or immunologics within 2 weeks prior to sinus surgery or during follow-up to day 30.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Serious Adverse Events | Up to 25 days after surgery | Rate of serious adverse events related to the use of the OCEAN bioresorbable nasal dressing post nasal surgery |
| Performance | Up to 25 days after surgery | 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) |
Countries
United States
Outcome results
None listed