Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)ESSPACK-2024NCT07862283
Chitosan-Based, Gelatin Sponge and Non-absorbable Nasal Packing After Endoscopic Sinus Surgery
A study testing PosiSep X, Spongostan and Osseous polyvinyl alcohol sinus pack (EON Meditech) in people with Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP), run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
- What is being tested?
- PosiSep X, Spongostan and Osseous polyvinyl alcohol sinus pack (EON Meditech)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital
Adapazarı, Sakarya, 54100
About this study
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
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.
Read the detailed description
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.
- Being tested
- PosiSep X, Spongostan, Osseous polyvinyl alcohol sinus pack (EON Meditech)
- Keywords
- Endoscopic sinus surgery, Nasal packing, Chitosan, Gelatin sponge, Polyvinyl alcohol, Synechia, Postoperative bleeding, Postoperative pain
- Medical subject headings
- Postoperative Hemorrhage, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PosiSep XDevice
Chitosan (poly-D-glucosamine) bioresorbable nasal dressing, single application at the end of surgery
SpongostanDevice
Absorbable gelatin sponge, single application at the end of surgery
Osseous polyvinyl alcohol sinus pack (EON Meditech)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Chitosan-based bioresorbable pack (PosiSep X) | Experimental | 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 Receives: Device: PosiSep X |
| Absorbable gelatin sponge (Spongostan) | Active comparator | Absorbable porcine gelatin sponge placed at the end of ESS; residual material removed or irrigated out at 48 hours Receives: Device: Spongostan |
| Non-absorbable PVA sinus pack | Active comparator | Non-absorbable expandable polyvinyl alcohol sponge placed at the end of ESS and removed at 48 hours Receives: Device: Osseous polyvinyl alcohol sinus pack (EON Meditech) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain with the pack in situ
Visual analogue scale, 0 (no pain) to 10 (worst imaginable pain)
Measured: 48 hours after surgery, before pack removal
Pain at pack removal
Visual analogue scale, 0-10
Measured: At pack removal, 48 hours after surgery
Secondary outcomes (4)
Postoperative bleeding grade
0 none; 1 minimal, confined to the nasal cavity; 2 moderate, extending beyond the nasal cavity; 3 severe, requiring re-packing
Measured: First 24 hours after surgery
Nasal Obstruction Symptom Evaluation (NOSE) score
Five items scored 0-4, total 0-20; higher scores indicate greater obstruction
Measured: 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
Measured: 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
Measured: Postoperative weeks 1 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start15 Oct 2024
- Primary completion25 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Three consecutive groups of 20 patients; the packing material was assigned by order of enrolment, with the order of materials determined by drawing lots (patients 1-20 PosiSep X, 21-40 Spongostan, 41-60 PVA sinus pack)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMET ERDEM, Sakarya University
- Investigators
- Mahmut Sinan Yılmaz, MD, Study chair, Sakarya University Training and Research HospitalAhmet Faruk Erdem, MD, Principal investigator, Sakarya University Training and Research HospitalWaheeb Damery, MD, Principal investigator, Sakarya University Training and Research HospitalHalil Elden, MD, Study director, Sakarya University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862283
- Sponsor's protocol ID
- SAU-ENT-ESSPACK-2024
- Other IDs
- E-43012747-050.04-409984-77
- Acronym
- ESSPACK-2024
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07862283
- Acronym / sponsor ID
- ESSPACK-2024 / SAU-ENT-ESSPACK-2024
- Keywords
- Endoscopic sinus surgery, Nasal packing, Chitosan, Gelatin sponge, Polyvinyl alcohol, Synechia, Postoperative bleeding, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three consecutive groups of 20 patients; the packing material was assigned by order of enrolment, with the order of materials determined by drawing lots (patients 1-20 PosiSep X, 21-40 Spongostan, 41-60 PVA sinus pack)
| Arm | Type | Receives |
|---|---|---|
| Chitosan-based bioresorbable pack (PosiSep X) | Experimental | Device: PosiSep XChitosan-based bioresorbable nasal dressing placed in the middle meatus and ethmoid cavity at the end of ESS; residual material irrigated out at 48 hours |
| Absorbable gelatin sponge (Spongostan) | Active comparator | Device: SpongostanAbsorbable porcine gelatin sponge placed at the end of ESS; residual material removed or irrigated out at 48 hours |
| Non-absorbable PVA sinus pack | Active comparator | Device: Osseous polyvinyl alcohol sinus pack (EON Meditech)Non-absorbable expandable polyvinyl alcohol sponge placed at the end of ESS and removed at 48 hours |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PosiSep XChitosan (poly-D-glucosamine) bioresorbable nasal dressing, single application at the end of surgery | Device | Chitosan-based bioresorbable pack (PosiSep X) |
| SpongostanAbsorbable gelatin sponge, single application at the end of surgery | Device | Absorbable gelatin sponge (Spongostan) |
| 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 | Device | Non-absorbable PVA sinus pack |
Primary outcome
Postoperative pain with the pack in situ
Time frame: 48 hours after surgery, before pack removal
Visual analogue scale, 0 (no pain) to 10 (worst imaginable pain)
Pain at pack removal
Time frame: At pack removal, 48 hours after surgery
Visual analogue scale, 0-10
4 secondary outcomes
Postoperative bleeding grade
Time frame: First 24 hours after surgery
Nasal Obstruction Symptom Evaluation (NOSE) score
Time frame: Postoperative day 2 and 1 month
Endoscopic adhesion (synechia) score
Time frame: Postoperative weeks 1 and 4
Endoscopic mucopurulent discharge score
Time frame: Postoperative weeks 1 and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Not yet recruitingObservational study
The German National CRS Registry (GenreCRS): Clinical Evaluation of the New European Academy for Allergy and Clinical Immunology (EAACI) Criteria for CRSwNP Disease Control, Remission and Cure in a Real-World Evidence Study Approach
Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmut Sinan Yılmaz, MD study chair
Sakarya University Training and Research Hospital
Ahmet Faruk Erdem, MD principal investigator
Sakarya University Training and Research Hospital
Waheeb Damery, MD principal investigator
Sakarya University Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PosiSep X, Spongostan and Osseous polyvinyl alcohol sinus pack (EON Meditech) in people with Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP), run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain with the pack in situ (time frame: 48 hours after surgery, before pack removal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.