Effects of STB* wound dressing on nasal wound healing after radiofrequent coblation of the inferior turbinate

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 64

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

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective: is there a significant difference in the overall nasal VAS<br /><br>symptom score between saline only nasal irrigations versus saline nasal<br /><br>irrigations and nasal application of STB* wound dressing?<br /><br>The primary endpoint will be the overall VAS symptom score after 6 weeks of<br /><br>treatment (initial treatment), comparing the two different treatments arms.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary parameters:<br /><br>- Comparison of nasal patency by means of NL-NOSE scale (questionnaire)<br /><br>- Comparison of nasal endoscopic findings (NES score)<br /><br>- Comparison of PNIF-score before and after treatment.<br /><br>- Comparison of the burden of epistaxis (5-point scale).<br /><br>- Comparison of the burden of nasal discharge (5-point scale).<br /><br>- Difference in VAS symptom score for crust formation. (VAS)<br /><br>- Difference in VAS symptom score for nasal pain. (VAS)<br /><br>- Difference in VAS symptom score for loss of smell. (VAS)</p><br>