Efficacy of PuraSinus Versus Bioresorbable Nasal Dressings

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

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 Overview

• Status: Active, not recruiting
• Conditions: Surgery; Chronic Sinus Disease
• Intervention / Treatment: Device: PuraSinus; Device: Bioresorbable Nasal Dressing

Detailed Description

Postoperative formation of adhesions, scarring, synechiae, ostial stenosis and edema are major concerns often addressed by the placement of bioresorbable packing intraoperatively. Bioresorbable packing has been demonstrated to decrease the incidence of adhesions and bleeding while improving patient comfort compared to no packing at all. However, bioresorbable nasal dressings oftentimes have not dissolved by the time of the first postoperative debridement 1-2 weeks after the surgery and therefore need to be removed. The removal of bioresorbable packing during postoperative debridements is usually an uncomfortable experience for the patient. An ideal nasal dressing would optimize both patient comfort as well as wound healing.

This is a prospective randomized controlled multicenter study at the University of Southern California and Northwestern University that will enroll at least 30 participants who satisfy criteria to compare the efficacy of PuraSinus versus standard of care in patients undergoing endoscopic sinus surgery. The study will utilize an intra-patient control design to assess the safety and efficacy of PuraSinus compared to bioresorbable packing on the contralateral side. The study patients will undergo PuraSinus placement in one nasal cavity following traditional endoscopic sinus surgery. The study is blinded, meaning that patients will be blinded throughout the study duration to which side received PuraSinus placement. The independent surgeon performing review of the video-endoscopies will also be blinded to which side received PuraSinus.

The patient will undergo follow-up assessments including endoscopic examination at three (3) post-operative visits at week 1, week 4, and week 12. A postoperative endoscopic debridement of the ethmoid cavities will be performed bilaterally at week 1. Primary and secondary outcomes will be assessed during the postoperative visits.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PuraSinus; Placement of PuraSinus in ethmoid cavity following ESS	Device: PuraSinus; A randomized ethmoid cavity in the patient will have PuraSinus applied to the ethmoid cavity after completion of an endoscopic total ethmoidectomy.
Active Comparator: Bioresorbable Nasal Dressing; Placement of bioresorbable nasal dressing (PosiSep X) in ethmoid cavity following ESS	Device: Bioresorbable Nasal Dressing; PosiSep X will be applied to the ethmoid cavity after completion of an endoscopic total ethmoidectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Debridement time	Time required to perform sinonasal cavity debridement for ethmoid cavity 1 week after surgery	1 week after surgery
Wound healing	Postoperative healing assessment of mucosal edema, crusting, secretions, and polyps 1 week, 4 weeks, and 12 weeks using validated Lund-Kennedy scoring rubric.	1, 4, and 12 weeks after surgery
Adhesions	Presence of adhesions at 1 week, 4 weeks and 12 weeks.	1, 4, and 12 weeks after surgery
Bleeding	Severity of bleeding during week 1 debridement	1 week after surgery
Residual dressing	Amount of residual PuraSinus or bioresorbable dressing in ethmoid cavity 1 week after surgery	1 week after surgery
Need for intervention	The need for further intervention postoperatively 4 weeks after surgery as evaluated by an independent blinded reviewer of the video-endoscopy	4 weeks after surgery

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: July 11, 2021
• First Submitted That Met QC Criteria: July 11, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: sinus surgery; chronic rhino sinusitis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Paranasal Sinus Diseases
• Other Study ID Numbers: 21-03390

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes