An interventional study of PosiSep X and Spongostan in Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP), sponsored by Sakarya University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Sakarya University · Not applicable, Interventional, and Supportive care
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.
Adults aged 18-75 years undergoing primary ESS with middle turbinate preservation for medically refractory chronic rhinosinusitis without nasal polyps were enrolled. Patients were allocated in three consecutive blocks of 20 by order of enrolment; the order in which the materials were used was determined by drawing lots before enrolment (patients 1-20 PosiSep X, 21-40 Spongostan, 41-60 PVA sinus pack). All patients received the same surgical technique (Messerklinger), the same postoperative protocol (oral antibiotic and analgesic for 7 days, saline irrigation from postoperative day 1) and had the packing material removed or irrigated out 48 hours after surgery. Postoperative bleeding was graded 0-3 within 24 hours. Pain was rated on a 0-10 visual analogue scale with the pack in situ and at removal. Nasal obstruction was assessed with the Turkish version of the NOSE scale on postoperative day 2 and at 1 month. Endoscopic examinations at weeks 1 and 4 graded adhesions (0-3) and mucopurulent discharge (0-3); the assessor was not informed of the packing material. The study was registered retrospectively after completion of follow-up; no changes were made to the protocol or outcome measures.
145 studies on the registry are indexed under Postoperative Hemorrhage; 27 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 104 interventional studies indexed under Postoperative Hemorrhage.
Browse Postoperative Hemorrhage studies →Sakarya University is the lead sponsor of 183 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Chitosan-based bioresorbable nasal dressing placed in the middle meatus and ethmoid cavity at the end of ESS; residual material irrigated out at 48 hours
Device: PosiSep X
Absorbable porcine gelatin sponge placed at the end of ESS; residual material removed or irrigated out at 48 hours
Device: Spongostan
Non-absorbable expandable polyvinyl alcohol sponge placed at the end of ESS and removed at 48 hours
Device: Osseous polyvinyl alcohol sinus pack (EON Meditech)
Chitosan (poly-D-glucosamine) bioresorbable nasal dressing, single application at the end of surgery
Absorbable gelatin sponge, single application at the end of surgery
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
Postoperative pain with the pack in situ
Visual analogue scale, 0 (no pain) to 10 (worst imaginable pain)
Time frame: 48 hours after surgery, before pack removal
Pain at pack removal
Visual analogue scale, 0-10
Time frame: At pack removal, 48 hours after surgery
Postoperative bleeding grade
0 none; 1 minimal, confined to the nasal cavity; 2 moderate, extending beyond the nasal cavity; 3 severe, requiring re-packing
Time frame: First 24 hours after surgery
Nasal Obstruction Symptom Evaluation (NOSE) score
Five items scored 0-4, total 0-20; higher scores indicate greater obstruction
Time frame: Postoperative day 2 and 1 month
Endoscopic adhesion (synechia) score
0 none; 1 minimal, easily separable; 2 moderate, partially narrowing the passage; 3 severe, requiring lysis
Time frame: Postoperative weeks 1 and 4
Endoscopic mucopurulent discharge score
0 none; 1 mild mucopurulent secretion with minimal erythema; 2 moderate (granulation, marked purulent secretion, widespread erythema); 3 severe
Time frame: Postoperative weeks 1 and 4
Plan to share: No — Individual participant data will not be made publicly available. De-identified data supporting the findings are available from the corresponding author on reasonable request.
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Dec 2025, 14 months.
Of 34 non-industry interventional studies with no phase under Postoperative Hemorrhage, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 33. This study's 14 months is close to that.
Counting every sponsor, half of 37 studies reached it within 15 months; a quarter within 8 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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