Occlusive wound healing after endonasal endoscopic sinus surgery – a prospective randomized trial
Phase 2
- Conditions
- j32.4Chronic pansinusitis
- Registration Number
- DRKS00009790
- Lead Sponsor
- HNO-KlinikUniklinik Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Age >/= 18 years
- bilateral endonasal endoscopic sinus surgery: maxillary sinusotomy, anterior and posterior ethmoidectomy, frontal sinus drainage Draf IIa
- chronic rhinosinusitis with nasal polyps not responding to medical treatment (at least topical steroids for 6 weeks, nasal douches, antibiotics for 3 weeks if indicated, systemic steroids if indicated)
- informed consent
- compliance with the study protocol
Exclusion Criteria
- no consent
- diseases that affect wound healing (AIDS, cystic fibrosis, immune deficiency, neutropenia)
- coagulation disorders or anticoagulants up to 7 days preoperatively
- indications for sinus surgery other than CRSwNP
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome: sinunasal wound healing 2 weeks postoperatively according to endoscopic score by Valentine 2010. <br>Hypothesis: Occlusion of the nose will lead to a faster wound healing after endoscopic sinus surgery.
- Secondary Outcome Measures
Name Time Method Secondary outcome:<br>- patient comfort measured by VAS 2, 3, 4, 12 weeks and 1 year postoperatively<br>- sinunasal wound healing after 3, 4, 12 weeks and 1 year after surgery according to endoscopic score by Valentine 2010<br>- the duration of each aftercare visit in minutes 2, 3, 4 weeks postoperatively<br>-size of the maxillary and frontal sinus neo-ostium in mm 3 months and 1 year postoperatively meassured with 3 mm suction instrument<br>