Inferior cocha/ inferior turbinate
Conditions
Interventions
Subjects in group 1 will be treated 3 times daily during 6 weeks with saline
nasal irrigations only. Group 2 will be treated withsaline nasal irrigations
and nasal application of STB* wound dressing
Sponsors
Isala Klinieken
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must have a diagnosis of bilateral inferior turbinate hypertrophy for > 6 weeks 2. Patients are capable of undergoing the coblation procedure under local anesthesia 3. Age * 18 and * 70 years. 4. Subjects must be willing to give Informed Consent and adhere to visit schedules.
Exclusion criteria
Exclusion criteria: 1. Subjects currently treated with anticoagulation other than thrombocyte aggregation inhibitors. 2. The presence of nasal polyps. 3. Known systemic vasculitic and granulomatous disease. 4. Known coagulopathy. 5. Known peanut allergy. 6. AIDS or known to be HIV positive. 7. Smoking (in the past 6 months). 8. History of radiotherapy in head and neck region. 9. History of previous turbinate surgery 10. Severe anatomic abnormalities leading to an inability to administer the irrigation solution to one side of the nose. 11. Nose valve insufficiency. 12. Craniofacial malformations. 13. Abnormalities requiring other modality of therapy (obstructive polyps, tumors, infection of dental origin). 14. Subject has a psychiatric, addictive, or any disorder that compromises ability to give truly Informed Consent for participation in this study. 15. Subject may have difficulty in interpreting the questionnaires due to language or cognitive problems. 16. Patient is currently enrolled in other investigational drug trial(s) or is receiving other investigational agent(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: is there a significant difference in the overall nasal VAS symptom score between saline only nasal irrigations versus saline nasal irrigations and nasal application of STB* wound dressing? The primary endpoint will be the overall VAS symptom score after 6 weeks of treatment (initial treatment), comparing the two different treatments arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary parameters: - Comparison of nasal patency by means of NL-NOSE scale (questionnaire) - Comparison of nasal endoscopic findings (NES score) - Comparison of PNIF-score before and after treatment. - Comparison of the burden of epistaxis (5-point scale). - Comparison of the burden of nasal discharge (5-point scale). - Difference in VAS symptom score for crust formation. (VAS) - Difference in VAS symptom score for nasal pain. (VAS) - Difference in VAS symptom score for loss of smell. (VAS) | — |
Countries
Netherlands
Outcome results
None listed