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Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings
NA trial testing PuraSinus in Chronic Sinus Disease in 30 participants. Completed in 5 May 2024.
| Lead sponsor | University of Southern California |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 January 2022 |
| Primary completion | 15 April 2024 |
| Estimated completion | 5 May 2024 |
| Sites | 1 location across United States |
University of Southern California
18 and older, any sex, with Chronic Sinus Disease or Surgery. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Hydrogel (Treatment Side) | 4 | 2.5 – 5.5 |
| Chitosan-based Polymer (Control) | 5 | 4 – 6 |
Time required to perform sinonasal cavity debridement for ethmoid cavity 1 week after surgery
| Group | Value | 95% CI |
|---|---|---|
| Hydrogel (Treatment Side) | 1.96 | 1.05 – 2.89 |
| Chitosan-based Polymer (Control) | 1.57 | 1.08 – 2.06 |
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
| Group | Value | 95% CI |
|---|---|---|
| Hydrogel (Treatment Side) | 24 | |
| Chitosan-based Polymer (Control) | 24 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Hydrogel (Treatment Side) | 1 | |
| Chitosan-based Polymer (Control) | 1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Hydrogel (Treatment Side) | 23 | |
| Chitosan-based Polymer (Control) | 23 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Hydrogel (Treatment Side) | 9 | |
| Chitosan-based Polymer (Control) | 13 |
The need for further intervention postoperatively 4 weeks after surgery as evaluated by an independent blinded reviewer of the video-endoscopy
| Group | Value | 95% CI |
|---|---|---|
| Hydrogel (Treatment Side) | 1 | |
| Chitosan-based Polymer (Control) | 4 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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