CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
PuraSinus +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04970966
NCT04970966N/ACompleted

Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings in Improving Patient Comfort During Postoperative Debridements

University of Southern California·interventional·Posted Jul 21, 2021·Updated Feb 11, 2026

In Brief

A clinical study evaluating PuraSinus and Bioresorbable Nasal Dressing for Chronic Sinus Disease and Surgery. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 21, 2021
Enrollment StartJan 1, 2022
Primary CompletionApr 15, 2024
Study CompletionMay 5, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.9 years ago

Interventions

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.