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Completed
NCT07862283
Chitosan-Based, Gelatin Sponge and Non-absorbable Nasal Packing After Endoscopic Sinus Surgery
Conditions: Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Sakarya University
Location: Sakarya University Training and Research Hospital Adapazarı Sakarya
Summary
This single-centre prospective study compared three nasal packing materials used after endoscopic sinus surgery (ESS) in adults with chronic rhinosinusitis without nasal polyps: a chitosan-based bioresorbable pack (PosiSep X), an absorbable gelatin sponge (Spongostan) and a non-absorbable polyvinyl alcohol (PVA) sinus pack. Sixty patients were allocated in three consecutive blocks of 20 by order of enrolment, with the order of materials determined by drawing lots (first 20 PosiSep X, next 20 Spongostan, last 20 PVA sinus pack); all materials were removed 48 hours after surgery. The study evaluated postoperative pain (visual analogue scale) with the pack in place and at removal, postoperative bleeding within the first 24 hours, nasal obstruction (NOSE score) on postoperative day 2 and at 1 month, and endoscopic adhesion and mucopurulent discharge scores at postoperative weeks 1 and 4.
Eligibility Criteria
Inclusion Criteria:
* Age 18 to 75 years
* Chronic rhinosinusitis without nasal polyps diagnosed according to EPOS 2020 criteria and refractory to appropriate medical therapy
* Scheduled for primary endoscopic sinus surgery with preservation of the middle turbinate
* Written informed consent
Exclusion Criteria:
* Nasal polyposis
* Sinonasal tumour or mass
* Revision endoscopic sinus surgery
* Surgery on the middle turbinate or middle turbinate variants (e.g. concha bullosa) requiring intervention
* Bleeding diathesis or anticoagulant/antiplatelet therapy
* Systemic disease affecting the nose (granulomatosis with polyangiitis, cystic fibrosis, primary ciliary dyskinesia, sarcoidosis)
* Pregnancy
* History of malignancy
Source: ClinicalTrials.gov (NCT07862283). StuddyBuddy aggregates publicly available trial information.