Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings

Completed · Not applicable

Conditions studied: Chronic Sinus Disease, Surgery

In brief

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.

Key facts

Study ID: NCT04970966
Run by: University of Southern California
People needed: 30
Starts: 2022-01-01
Expected to finish: 2024-05-05
Last updated by the study team: 2026-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Keck Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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