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NCT04970966 · ClinicalTrials.gov registry record · NA
Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings
A NA study, sponsored by University of Southern California.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT04970966: Completed NA study, sponsored by University of Southern California.
NCT04970966 is a NA study that has completed, run by University of Southern California. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04970966, a NA study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE PuraSinus
- DEVICE Bioresorbable Nasal Dressing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-01-01 |
| Est. Completion | 2024-05-05 |
| Phase | NA |
What the finished NCT04970966 record still lists
NCT04970966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which PuraSinus is the first listed.
NCT04970966 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04970966 about?
NCT04970966 is a clinical study titled "Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings". 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 ...
What is the current status of trial NCT04970966?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2022-01-01. Estimated completion is 2024-05-05.
What interventions are being tested in trial NCT04970966?
The interventions under investigation include: PuraSinus (DEVICE), Bioresorbable Nasal Dressing (DEVICE).
Who is sponsoring clinical trial NCT04970966?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04970966's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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