Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPolyganics BV
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is 18 years or older
Patient is scheduled to undergo bilateral endoscopic sinus surgery for Chronic Rhinosinusitis with nasal polyps (CRSwNP) or Chronic Rhinosinusitis without nasal polyps (CRSsNP)
Patient is willing and able to comply with all study elements as indicated by their written informed consent
Patients with a pre-operative Lund-MacKay score of ≥ 6.
Disqualifiers
Patient is pregnant or nursing
Patients with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months
Patients with a platelet disorder
Patients with a known or suspected allergy to device components
Trial design
Design model
Single group
Treatments tested in this trial
OCEAN
DeviceBiodegradable nasal dressing
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: OCEANExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety
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 surgery2
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 surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Polyganics BV
Lead sponsor
NAMSA
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: