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| Name | Class |
|---|---|
| Northwestern University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PuraSinus | Experimental | Placement of PuraSinus in ethmoid cavity following ESS |
|
| Bioresorbable Nasal Dressing | Active Comparator | Placement of bioresorbable nasal dressing (PosiSep X) in ethmoid cavity following ESS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PuraSinus | Device | A randomized ethmoid cavity in the patient will have PuraSinus applied to the ethmoid cavity after completion of an endoscopic total ethmoidectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Debridement Time | Time required to perform sinonasal cavity debridement for ethmoid cavity 1 week after surgery | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Medical Center | Los Angeles | California | 90033 | United States |
This was a split-person (within-participant) design: each participant contributed one ethmoid cavity to the Hydrogel arm and the contralateral cavity to the Chitosan arm. Therefore, the same participants are counted in both arms within a Milestone row, which is expected.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydrogel (Treatment Side) | Participant had hydrogel placed in ethmoid cavity. |
| FG001 | Chitosan-based Polymer (Control) | Participant had chitosan-based polymer placed in ethmoid cavity |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 Follow-up |
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| Week 4 Follow-up |
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| Weed 12 Follow-up |
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All randomized participants who underwent bilateral total ethmoidectomy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants | All randomized participants who underwent bilateral total ethmoidectomy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Pain Score | 1 week after surgery |
|
from enrollment until end of follow-up, up to 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hydrogel (Treatment Side) | Participants who received hydrogel in at least one ethmoid cavity |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Hur | University of Southern California | 323-442-5790 | kevinhur@usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2021 | Jan 10, 2026 | Prot_SAP_000.pdf |
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Intra-patient control
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| Bioresorbable Nasal Dressing | Device | PosiSep X will be applied to the ethmoid cavity after completion of an endoscopic total ethmoidectomy. |
|
| 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. | 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. | 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. | 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 | 4 weeks after surgery |
| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| History of Endoscopic Sinus Surgery | Count of Participants | Participants |
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| Nasal Polyps | Count of Participants | Participants |
|
| Allergic Rhinitis | Count of Participants | Participants |
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| Asthma | Count of Participants | Participants |
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| Diabetes | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Debridement Time | Time required to perform sinonasal cavity debridement for ethmoid cavity 1 week after surgery | Posted | Median | Inter-Quartile Range | minutes | 1 week after surgery |
|
|
|
| Secondary | 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 | Data were available for 28 participants per arm at this time point. | Posted | Count of Participants | Participants | 4 weeks after surgery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 weeks after surgery |
|
|
|
| Secondary | 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. | Two participants did not have evaluable endoscopic data at this time point and were excluded from this analysis. | Posted | Count of Participants | Participants | 1 week after surgery |
|
|
|
| Secondary | 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. | Two participants did not have evaluable endoscopic data at this time point and were excluded from this analysis. | Posted | Count of Participants | Participants | 1 week after surgery |
|
|
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| Secondary | 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 | Posted | Count of Participants | Participants | 4 weeks after surgery |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Chitosan-based Polymer (Control) | Participants who received chitosan dressing in at least one ethmoid cavity | 0 | 30 | 0 | 30 | 0 | 30 |
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