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Occlusive wound healing after endonasal endoscopic sinus surgery – a prospective randomized trial

Occlusive wound healing after endonasal endoscopic sinus surgery – a prospective randomized trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00009790
Enrollment
174
Registered
2015-12-29
Start date
2015-12-10
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

j32.4

Interventions

Group 1: - topical nasal steroid (2 x 2 puffs daily) for 12 months - nasal douches 3 x daily - antibiotics (cephalosoprin i.v. preoperatively, Doxycyclin 100 mg OD, if allergic Cotrim forte 2 x 960 mg

Sponsors

HNO-KlinikUniklinik Freiburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Primary outcome: sinunasal wound healing 2 weeks postoperatively according to endoscopic score by Valentine 2010. Hypothesis: Occlusion of the nose will lead to a faster wound healing after endoscopic sinus surgery.

Secondary

MeasureTime frame
Secondary outcome: - patient comfort measured by VAS 2, 3, 4, 12 weeks and 1 year postoperatively - sinunasal wound healing after 3, 4, 12 weeks and 1 year after surgery according to endoscopic score by Valentine 2010 - the duration of each aftercare visit in minutes 2, 3, 4 weeks postoperatively -size of the maxillary and frontal sinus neo-ostium in mm 3 months and 1 year postoperatively meassured with 3 mm suction instrument

Countries

Czechia, Germany

Contacts

Public ContactTanja Hildenbrand

HNO-KlinikUniklinik Freiburg

tanja.hildenbrand@uniklinik-freiburg.de0761/27042010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026