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COMPLETED
NCT07862283
NA

Chitosan-Based, Gelatin Sponge and Non-absorbable Nasal Packing After Endoscopic Sinus Surgery

Sponsor: Sakarya University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-10-15

Completion Date

2025-12-30

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

DEVICE

PosiSep X

Chitosan (poly-D-glucosamine) bioresorbable nasal dressing, single application at the end of surgery

DEVICE

Spongostan

Absorbable gelatin sponge, single application at the end of surgery

DEVICE

Osseous polyvinyl alcohol sinus pack (EON Meditech)

Non-absorbable polyvinyl alcohol sponge sinus pack with retrieval string (Osseous, EON Meditech Pvt. Ltd., Surat, India), single application at the end of surgery, removed at 48 hours

Locations (1)

Sakarya University Training and Research Hospital

Adapazarı, Sakarya, Turkey (Türkiye)