Effects of STB™ wounddressing on nasal woundhealing after radiofrequency coblation treatment of the inferior turbinates

Completed

• Conditions: Inferior turbinate hypertrophy

• Registration Number: NL-OMON24055
• Lead Sponsor: Dos Medical B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

1.Subjects must have a diagnosis of bilateral ITH 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.History of radiotherapy in head and neck region.
8.History of previous turbinate surgery
9.Severe anatomic abnormalities leading to an inability to administer the irrigation solution to one side of the nose (for example a severe septal deviation or a large bullous middle turbinate).
10.Craniofacial malformations.
11.Abnormalities requiring other modality of therapy (obstructive polyps, tumors, infection of dental origin).
12.Subject has a psychiatric, addictive, or any disorder that compromises ability to give truly Informed Consent for participation in this study.
13.Subject may have difficulty in interpreting the questionnaires due to language or cognitive problems.
14.Patient is currently enrolled in other investigational drug trial(s) or is receiving other investigational agent(s).

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Difference in mean overall nasal VAS symptom score between the two arms after 6 weeks.

Secondary Outcome Measures

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