Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings

NCT04970966 | Completed Results DMC FDA Device

• 1 other identifier: 21-03390
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Sinus Disease; Surgery

Keywords

sinus surgery; chronic rhino sinusitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Debridement Time

  1 week after surgery

• Number of Participants With Mucosal Edema

  4 weeks after surgery

• Number of Participants With Postoperative Adhesions at 12 Weeks

  12 weeks after surgery

• Number of Participants With Postoperative Bleeding at Week 1 Debridement

  1 week after surgery

• Number of Participants With Greater Than 50% Residual Dressing in Ethmoid Cavity at Week 1

  1 week after surgery

Study Arms (2)

PuraSinus

EXPERIMENTAL

Placement of PuraSinus in ethmoid cavity following ESS

Device: PuraSinus

Bioresorbable Nasal Dressing

ACTIVE COMPARATOR

Placement of bioresorbable nasal dressing (PosiSep X) in ethmoid cavity following ESS

Device: Bioresorbable Nasal Dressing

Interventions

PuraSinus DEVICE

A randomized ethmoid cavity in the patient will have PuraSinus applied to the ethmoid cavity after completion of an endoscopic total ethmoidectomy.

PuraSinus

Bioresorbable Nasal Dressing DEVICE

PosiSep X will be applied to the ethmoid cavity after completion of an endoscopic total ethmoidectomy.

Bioresorbable Nasal Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Southern California: lead
• Northwestern University: collaborator

Study Sites (1)

Keck Medical Center

Los Angeles, California, 90033, United States

Location

Results Point of Contact

• Title: Kevin Hur
• Organization: University of Southern California

kevinhur@usc.edu

323-442-5790

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intra-patient control

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: July 21, 2021
• Study Start: January 1, 2022
• Primary Completion: April 15, 2024
• Study Completion: May 5, 2024
• Last Updated: February 11, 2026
• Results First Posted: February 11, 2026

Record last verified: 2026-02

Locations

US (1)