Chitosan-Based, Gelatin Sponge and Non-absorbable Nasal Packing After Endoscopic Sinus Surgery
CompletedNot applicableNCT07862283
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Chitosan-based Bioresorbable, Gelatin Sponge and Non-absorbable Polyvinyl Alcohol Nasal Packing After Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Nasal Polyps: a Prospective Comparative Study of Patient Comfort, Bleeding and Early Mucosal Healing
- Conditions
- Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
- Interventions
- Device: PosiSep X
- Device: Spongostan
- Device: Osseous polyvinyl alcohol sinus pack (EON Meditech)
- Sponsor
- Sakarya University
- Start date
- 2024-10-15
- Primary completion
- 2025-12-25
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Turkey (Türkiye)
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07862283