N/A
N=60
Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings
Chronic Sinus Disease · Surgery
Bottom Line
View on ClinicalTrials.gov: NCT04970966 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Pain During Debridement — 4; 5 Pain Score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PuraSinus (Device); Bioresorbable Nasal Dressing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain During Debridement |
4; 5 | — |
| SECONDARY Debridement Time |
1.96; 1.57 | — |
| SECONDARY Number of Participants With Mucosal Edema |
24; 24 | — |
| SECONDARY Number of Participants With Postoperative Adhesions at 12 Weeks |
1; 1 | — |
| SECONDARY Number of Participants With Postoperative Bleeding at Week 1 Debridement |
23; 23 | — |
| SECONDARY Number of Participants With Greater Than 50% Residual Dressing in Ethmoid Cavity at Week 1 |
9; 13 | — |
| SECONDARY Number of Participants Requiring Additional Postoperative Intervention by Week 4 |
1; 4 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04970966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.