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| Name | Class |
|---|---|
| NAMSA | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCEAN | Experimental | Application of OCEAN after nasal/sinus surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCEAN | Device | Biodegradable nasal dressing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Rate of serious adverse events related to the use of the OCEAN bioresorbable nasal dressing post nasal surgery | 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) | Up to 25 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carola Hartgers | Contact | 050 588 6582 | chartgers@regenity.com | |
| Betty IJmker | Contact | 050 588 6582 | bijmker@regenity.com |
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