Chronic Sinus DiseaseNCT04970966
Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings
A study testing PuraSinus and Bioresorbable Nasal Dressing in people with Chronic Sinus Disease and Surgery, run by University of Southern California at 1 site in United States.
Trial summary
Postoperative care of patients undergoing endoscopic sinus surgery (ESS) is important both to minimize discomfort for the patients and to obtain the optimal long-term outcomes. Postoperative sinonasal cavity debridement has been advocated to prevent potential synechiae and sinus ostial stenosis, as well as to improve… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Sinus Disease, Surgery
- What is being tested?
- PuraSinus and Bioresorbable Nasal Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 5 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient is 18 years of age or older
- Patient has a clinical indication for and has consented for primary or revision bilateral ESS and had evidence of ethmoid disease bilaterally (Lund-Mackay score at least 1 on each side).
- Diagnosed with CRS based on American Academy of Otolaryngology - Head and Neck Surgery guidelines
Who cannot join
- Patient has a known history of immune deficiency such as immunoglobulin G or A subclass deficiency, or Human Immunodeficiency Virus (HIV).
- Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g. cancer, HIV, etc.)
- Patient has clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90 day followup period.
- Patient is currently participating in another clinical trial.
- Patient has a known coagulation disorder.
- Patient is allergic to shellfish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings in Improving Patient Comfort During Postoperative Debridements
Postoperative care of patients undergoing endoscopic sinus surgery (ESS) is important both to minimize discomfort for the patients and to obtain the optimal long-term outcomes. Postoperative sinonasal cavity debridement has been advocated to prevent potential synechiae and sinus ostial stenosis, as well as to improve patient symptoms. Removal of old blood, nasal secretions, crusting, and unabsorbed packing are thought to reduce the inflammatory load, minimize potential for scarring, and allow for improved access of topical medications. However, the debridement procedure can cause bleeding, pain, and discomfort which may interfere with the effective execution of postoperative care.
PuraSinus is a novel topical haemostatic agent based on nanotechnologies in the form of a transparent hydrogel suitable for endoscopic use and for which the use in sinonasal surgery could achieve these various goals. The potential of PuraSinus to enhance endoscopic mucosal wound healing may play a role in optimizing patient comfort during postoperative debridements after ESS. However, clinical evidence on its effectiveness in ESS is limited.
The investigators aim to perform a randomized controlled trial to evaluate the efficacy of PuraSinus in improving patient comfort during postoperative debridements among patients who underwent ESS.
Read the detailed description
Postoperative formation of adhesions, scarring, synechiae, ostial stenosis and edema are major concerns often addressed by the placement of bioresorbable packing intraoperatively. Bioresorbable packing has been demonstrated to decrease the incidence of adhesions and bleeding while improving patient comfort compared to no packing at all. However, bioresorbable nasal dressings oftentimes have not dissolved by the time of the first postoperative debridement 1-2 weeks after the surgery and therefore need to be removed. The removal of bioresorbable packing during postoperative debridements is usually an uncomfortable experience for the patient. An ideal nasal dressing would optimize both patient comfort as well as wound healing.
This is a prospective randomized controlled multicenter study at the University of Southern California and Northwestern University that will enroll at least 30 participants who satisfy criteria to compare the efficacy of PuraSinus versus standard of care in patients undergoing endoscopic sinus surgery. The study will utilize an intra-patient control design to assess the safety and efficacy of PuraSinus compared to bioresorbable packing on the contralateral side. The study patients will undergo PuraSinus placement in one nasal cavity following traditional endoscopic sinus surgery. The study is blinded, meaning that patients will be blinded throughout the study duration to which side received PuraSinus placement. The independent surgeon performing review of the video-endoscopies will also be blinded to which side received PuraSinus.
The patient will undergo follow-up assessments including endoscopic examination at three (3) post-operative visits at week 1, week 4, and week 12. A postoperative endoscopic debridement of the ethmoid cavities will be performed bilaterally at week 1. Primary and secondary outcomes will be assessed during the postoperative visits.
- Conditions
- Chronic Sinus Disease, Surgery
- Being tested
- PuraSinus, Bioresorbable Nasal Dressing
- Keywords
- sinus surgery, chronic rhino sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PuraSinusDevice
A randomized ethmoid cavity in the patient will have PuraSinus applied to the ethmoid cavity after completion of an endoscopic total ethmoidectomy.
Bioresorbable Nasal DressingDevice
PosiSep X will be applied to the ethmoid cavity after completion of an endoscopic total ethmoidectomy.
| Study group | Role | What they receive |
|---|---|---|
| PuraSinus | Experimental | Placement of PuraSinus in ethmoid cavity following ESS Receives: Device: PuraSinus |
| Bioresorbable Nasal Dressing | Active comparator | Placement of bioresorbable nasal dressing (PosiSep X) in ethmoid cavity following ESS Receives: Device: Bioresorbable Nasal Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain During Debridement
Patient-reported pain visual analogue scale during postoperative debridement of ethmoid cavity. The minimum score is 1, which reflects no pain, and the maximum score is 10, which reflects an extreme amount of pain.
Measured: 1 week after surgery
Secondary outcomes (6)
Debridement Time
Time required to perform sinonasal cavity debridement for ethmoid cavity 1 week after surgery
Measured: 1 week after surgery
Number of Participants With Mucosal Edema
Mucosal edema was assessed via endoscopic examination at 4 weeks postoperatively. Edema was recorded as present or absent based on investigator visual assessment using standard postoperative sinus endoscopy criteria
Measured: 4 weeks after surgery
Number of Participants With Postoperative Adhesions at 12 Weeks
Adhesions were assessed during endoscopic examination at 12 weeks postoperatively. Presence of adhesions was determined by direct visualization of scar bands between the middle turbinate and lateral nasal wall.
Measured: 12 weeks after surgery
Number of Participants With Postoperative Bleeding at Week 1 Debridement
Bleeding was evaluated during the week 1 postoperative debridement visit. Presence of bleeding was recorded if any mucosal bleeding was visualized on nasal endoscopy in the ethmoid cavity.
Measured: 1 week after surgery
Number of Participants With Greater Than 50% Residual Dressing in Ethmoid Cavity at Week 1
Residual bioresorbable dressing material in the ethmoid cavity was assessed endoscopically at 1 week. Greater than 50% residual material was recorded when more than half of the originally placed dressing remained visible.
Measured: 1 week after surgery
Number of Participants Requiring Additional Postoperative Intervention by Week 4
The need for further intervention postoperatively 4 weeks after surgery as evaluated by an independent blinded reviewer of the video-endoscopy
Measured: 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Jan 2022
- Primary completion15 Apr 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Sinus DiseaseStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intra-patient control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Principal investigator, Kevin Hur, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970966
- Sponsor's protocol ID
- 21-03390
- Status last verified
- Feb 2026
- First submitted
- 11 Jul 2021
- Last updated
- 11 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings in Improving Patient Comfort During Postoperative Debridements
- ClinicalTrials.gov ID
- NCT04970966
- Acronym / sponsor ID
- 21-03390
- Conditions
- Chronic Sinus Disease, Surgery
- Keywords
- sinus surgery, chronic rhino sinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Posted 11 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative care of patients undergoing endoscopic sinus surgery (ESS) is important both to minimize discomfort for the patients and to obtain the optimal long-term outcomes. Postoperative sinonasal cavity debridement has been advocated to prevent potential synechiae and sinus ostial stenosis, as well as to improve patient symptoms. Removal of old blood, nasal secretions, crusting, and unabsorbed packing are thought to reduce the inflammatory load, minimize potential for scarring, and allow for improved access of topical medications. However, the debridement procedure can cause bleeding, pain, and discomfort which may interfere with the effective execution of postoperative care.
PuraSinus is a novel topical haemostatic agent based on nanotechnologies in the form of a transparent hydrogel suitable for endoscopic use and for which the use in sinonasal surgery could achieve these various goals. The potential of PuraSinus to enhance endoscopic mucosal wound healing may play a role in optimizing patient comfort during postoperative debridements after ESS. However, clinical evidence on its effectiveness in ESS is limited.
The investigators aim to perform a randomized controlled trial to evaluate the efficacy of PuraSinus in improving patient comfort during postoperative debridements among patients who underwent ESS.
Detailed description
Postoperative formation of adhesions, scarring, synechiae, ostial stenosis and edema are major concerns often addressed by the placement of bioresorbable packing intraoperatively. Bioresorbable packing has been demonstrated to decrease the incidence of adhesions and bleeding while improving patient comfort compared to no packing at all. However, bioresorbable nasal dressings oftentimes have not dissolved by the time of the first postoperative debridement 1-2 weeks after the surgery and therefore need to be removed. The removal of bioresorbable packing during postoperative debridements is usually an uncomfortable experience for the patient. An ideal nasal dressing would optimize both patient comfort as well as wound healing.
This is a prospective randomized controlled multicenter study at the University of Southern California and Northwestern University that will enroll at least 30 participants who satisfy criteria to compare the efficacy of PuraSinus versus standard of care in patients undergoing endoscopic sinus surgery. The study will utilize an intra-patient control design to assess the safety and efficacy of PuraSinus compared to bioresorbable packing on the contralateral side. The study patients will undergo PuraSinus placement in one nasal cavity following traditional endoscopic sinus surgery. The study is blinded, meaning that patients will be blinded throughout the study duration to which side received PuraSinus placement. The independent surgeon performing review of the video-endoscopies will also be blinded to which side received PuraSinus.
The patient will undergo follow-up assessments including endoscopic examination at three (3) post-operative visits at week 1, week 4, and week 12. A postoperative endoscopic debridement of the ethmoid cavities will be performed bilaterally at week 1. Primary and secondary outcomes will be assessed during the postoperative visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Intra-patient control
| Arm | Type | Receives |
|---|---|---|
| PuraSinus | Experimental | Device: PuraSinusPlacement of PuraSinus in ethmoid cavity following ESS |
| Bioresorbable Nasal Dressing | Active comparator | Device: Bioresorbable Nasal DressingPlacement of bioresorbable nasal dressing (PosiSep X) in ethmoid cavity following ESS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is 18 years of age or older
- Patient has a clinical indication for and has consented for primary or revision bilateral ESS and had evidence of ethmoid disease bilaterally (Lund-Mackay score at least 1 on each side).
- Diagnosed with CRS based on American Academy of Otolaryngology - Head and Neck Surgery guidelines
Key exclusion criteria (6 listed)
- Patient has a known history of immune deficiency such as immunoglobulin G or A subclass deficiency, or Human Immunodeficiency Virus (HIV).
- Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g. cancer, HIV, etc.)
- Patient has clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90 day followup period.
- Patient is currently participating in another clinical trial.
- Patient has a known coagulation disorder.
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 |
|---|---|---|
| PuraSinusA randomized ethmoid cavity in the patient will have PuraSinus applied to the ethmoid cavity after completion of an endoscopic total ethmoidectomy. | Device | PuraSinus |
| Bioresorbable Nasal DressingPosiSep X will be applied to the ethmoid cavity after completion of an endoscopic total ethmoidectomy. | Device | Bioresorbable Nasal Dressing |
Primary outcome
Pain During Debridement
Time frame: 1 week after surgery
Patient-reported pain visual analogue scale during postoperative debridement of ethmoid cavity. The minimum score is 1, which reflects no pain, and the maximum score is 10, which reflects an extreme amount of pain.
6 secondary outcomes
Debridement Time
Time frame: 1 week after surgery
Number of Participants With Mucosal Edema
Time frame: 4 weeks after surgery
Number of Participants With Postoperative Adhesions at 12 Weeks
Time frame: 12 weeks after surgery
Number of Participants With Postoperative Bleeding at Week 1 Debridement
Time frame: 1 week after surgery
Number of Participants With Greater Than 50% Residual Dressing in Ethmoid Cavity at Week 1
Time frame: 1 week after surgery
Number of Participants Requiring Additional Postoperative Intervention by Week 4
Time frame: 4 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PuraSinus and Bioresorbable Nasal Dressing in people with Chronic Sinus Disease and Surgery, run by University of Southern California at 1 site in United States.
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 3 inclusion and 6 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 11 Feb 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain During Debridement (time frame: 1 week after surgery). 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 11 Feb 2026.